XL+DEFIBRILLATOR
This device is manufactured by PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL, PHILIPS NORTH AMERICA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Heart Problem | 23 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Cardiac Arrest | 7 | Patient |
| 2024 | Arrhythmia | 2 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Abrasion | 1 | Patient |
| 2024 | Unintended Power Up | 1 | Device |
| 2024 | Unexpected Shutdown | 4 | Device |
| 2024 | Unable to Obtain Readings | 17 | Device |
| 2024 | Protective Measures Problem | 1 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Power Problem | 8 | Device |
| 2024 | Poor Quality Image | 1 | Device |
| 2024 | Peeled/Delaminated | 1 | Device |
| 2024 | Output below Specifications | 2 | Device |
| 2024 | Output Problem | 4 | Device |
| 2024 | Operating System Becomes Nonfunctional | 3 | Device |
| 2024 | No Pacing | 1 | Device |
| 2024 | No Display/Image | 7 | Device |
| 2024 | No Device Output | 2 | Device |
| 2024 | No Audible Prompt/Feedback | 1 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Moisture Damage | 1 | Device |
| 2024 | Missing Test Results | 1 | Device |
| 2024 | Mechanics Altered | 8 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Material Integrity Problem | 5 | Device |
| 2024 | Material Discolored | 1 | Device |
| 2024 | Loose or Intermittent Connection | 2 | Device |
| 2024 | Key or Button Unresponsive/not Working | 4 | Device |
| 2024 | Intermittent Continuity | 2 | Device |
| 2024 | Insufficient Information | 4 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 25 | Device |
| 2024 | Incorrect Measurement | 2 | Device |
| 2024 | Incomplete or Inadequate Connection | 1 | Device |
| 2024 | Inaudible or Unclear Audible Prompt/Feedback | 1 | Device |
| 2024 | Inappropriate Audible Prompt/Feedback | 4 | Device |
| 2024 | Human-Device Interface Problem | 2 | Device |
| 2024 | Fracture | 7 | Device |
| 2024 | Fitting Problem | 3 | Device |
| 2024 | Failure to Run on Battery | 4 | Device |
| 2024 | Failure to Power Up | 23 | Device |
| 2024 | Failure to Discharge | 4 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 47 | Device |
| 2024 | Failure to Deliver Energy | 2 | Device |
| 2024 | Failure to Conduct | 1 | Device |
| 2024 | Failure to Charge | 5 | Device |
| 2024 | Failure to Calibrate | 1 | Device |
| 2024 | Failure of Device to Self-Test | 93 | Device |
| 2024 | Energy Output Problem | 5 | Device |
| 2024 | Electrical /Electronic Property Problem | 45 | Device |
| 2024 | Display or Visual Feedback Problem | 5 | Device |
| 2024 | Display Difficult to Read | 1 | Device |
| 2024 | Device Fell | 2 | Device |
| 2024 | Device Displays Incorrect Message | 12 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Degraded | 5 | Device |
| 2024 | Defibrillation/Stimulation Problem | 10 | Device |
| 2024 | Computer Software Problem | 3 | Device |
| 2024 | Computer Operating System Problem | 1 | Device |
| 2024 | Circuit Failure | 1 | Device |
| 2024 | Break | 13 | Device |
| 2024 | Battery Problem | 41 | Device |
| 2024 | Audible Prompt/Feedback Problem | 4 | Device |
| 2024 | Accessory Incompatible | 2 | Device |
| 2023 | Unspecified Heart Problem | 7 | Patient |
| 2023 | Insufficient Information | 10 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Unintended Power Up | 4 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Unexpected Shutdown | 2 | Device |
| 2023 | Unclear Information | 1 | Device |
| 2023 | Unable to Obtain Readings | 34 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 8 | Device |
| 2023 | Sparking | 1 | Device |
| 2023 | Signal Artifact/Noise | 1 | Device |
| 2023 | Protective Measures Problem | 3 | Device |
| 2023 | Premature Discharge of Battery | 4 | Device |
| 2023 | Power Problem | 8 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Poor Visibility | 1 | Device |
| 2023 | Poor Quality Image | 1 | Device |
| 2023 | Physical Resistance/Sticking | 1 | Device |
| 2023 | Peeled/Delaminated | 1 | Device |
| 2023 | Pacing Problem | 3 | Device |
| 2023 | Output below Specifications | 1 | Device |
| 2023 | Output Problem | 4 | Device |
| 2023 | Operating System Version or Upgrade Problem | 1 | Device |
| 2023 | Operating System Becomes Nonfunctional | 2 | Device |
| 2023 | No Visual Prompts/Feedback | 1 | Device |
| 2023 | No Display/Image | 1 | Device |
| 2023 | Missing Test Results | 1 | Device |
| 2023 | Mechanical Problem | 8 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Integrity Problem | 8 | Device |
| 2023 | Material Discolored | 1 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Leak/Splash | 2 | Device |
| 2023 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2023 | Intermittent Loss of Power | 6 | Device |
| 2023 | Insufficient Information | 8 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 24 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Inappropriate Audible Prompt/Feedback | 3 | Device |
| 2023 | High Readings | 1 | Device |
| 2023 | Fracture | 6 | Device |
| 2023 | Fitting Problem | 11 | Device |
| 2023 | Fire | 1 | Device |
| 2023 | False Alarm | 1 | Device |
| 2023 | Failure to Run on Battery | 6 | Device |
| 2023 | Failure to Power Up | 26 | Device |
| 2023 | Failure to Discharge | 4 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 34 | Device |
| 2023 | Failure to Deliver Energy | 1 | Device |
| 2023 | Failure to Conduct | 9 | Device |
| 2023 | Failure to Charge | 7 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Failure to Analyze Signal | 3 | Device |
| 2023 | Failure to Align | 2 | Device |
| 2023 | Failure of Device to Self-Test | 106 | Device |
| 2023 | Energy Output Problem | 3 | Device |
| 2023 | Electrical /Electronic Property Problem | 35 | Device |
| 2023 | Display or Visual Feedback Problem | 7 | Device |
| 2023 | Display Difficult to Read | 1 | Device |
| 2023 | Disconnection | 3 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Device Markings/Labelling Problem | 2 | Device |
| 2023 | Device Fell | 6 | Device |
| 2023 | Device Displays Incorrect Message | 2 | Device |
| 2023 | Device Alarm System | 5 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Dent in Material | 1 | Device |
| 2023 | Degraded | 6 | Device |
| 2023 | Defibrillation/Stimulation Problem | 4 | Device |
| 2023 | Date/Time-Related Software Problem | 1 | Device |
| 2023 | Computer System Security Problem | 1 | Device |
| 2023 | Computer Software Problem | 3 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Component Incompatible | 1 | Device |
| 2023 | Circuit Failure | 2 | Device |
| 2023 | Charging Problem | 2 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Battery Problem | 31 | Device |
| 2023 | Audible Prompt/Feedback Problem | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Application Program Problem: Parameter Calculation Error | 1 | Device |
| 2023 | Accessory Incompatible | 6 | Device |
| 2022 | Ventricular Fibrillation | 1 | Patient |
| 2022 | Unspecified Heart Problem | 3 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Myocardial Infarction | 1 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Cardiac Arrest | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Visual Prompts will not Clear | 1 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unintended Power Up | 1 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Unclear Information | 1 | Device |
| 2022 | Unable to Obtain Readings | 14 | Device |
| 2022 | Signal Artifact/Noise | 4 | Device |
| 2022 | Protective Measures Problem | 1 | Device |
| 2022 | Power Problem | 4 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Output below Specifications | 1 | Device |
| 2022 | Output Problem | 4 | Device |
| 2022 | Operating System Becomes Nonfunctional | 1 | Device |
| 2022 | No Pacing | 1 | Device |
| 2022 | No Display/Image | 4 | Device |
| 2022 | No Audible Prompt/Feedback | 5 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Missing Test Results | 3 | Device |
| 2022 | Misassembly by Users | 1 | Device |
| 2022 | Mechanical Problem | 8 | Device |
| 2022 | Mechanical Jam | 1 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Loose or Intermittent Connection | 3 | Device |
| 2022 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2022 | Intermittent Loss of Power | 2 | Device |
| 2022 | Insufficient Information | 16 | Device |
| 2022 | Infusion or Flow Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2022 | Incorrect Measurement | 5 | Device |
| 2022 | Incomplete or Missing Packaging | 8 | Device |
| 2022 | Incomplete or Inadequate Connection | 2 | Device |
| 2022 | Inaudible or Unclear Audible Prompt/Feedback | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Inappropriate Audible Prompt/Feedback | 3 | Device |
| 2022 | Inadequate User Interface | 1 | Device |
| 2022 | Inadequate Lubrication | 1 | Device |
| 2022 | Fitting Problem | 2 | Device |
| 2022 | Failure to Run on Battery | 8 | Device |
| 2022 | Failure to Power Up | 18 | Device |
| 2022 | Failure to Discharge | 6 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 17 | Device |
| 2022 | Failure to Deliver Energy | 2 | Device |
| 2022 | Failure to Conduct | 27 | Device |
| 2022 | Failure to Charge | 4 | Device |
| 2022 | Failure to Analyze Signal | 1 | Device |
| 2022 | Failure of Device to Self-Test | 73 | Device |
| 2022 | Erratic or Intermittent Display | 1 | Device |
| 2022 | Erratic Results | 1 | Device |
| 2022 | Energy Output Problem | 2 | Device |
| 2022 | Electromagnetic Interference | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 12 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Display Difficult to Read | 1 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Displays Incorrect Message | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Device Difficult to Setup or Prepare | 1 | Device |
| 2022 | Device Alarm System | 1 | Device |
| 2022 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Defibrillation/Stimulation Problem | 2 | Device |
| 2022 | Defective Alarm | 1 | Device |
| 2022 | Computer Software Problem | 2 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Component Incompatible | 1 | Device |
| 2022 | Circuit Failure | 4 | Device |
| 2022 | Charging Problem | 3 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Battery Problem | 27 | Device |
| 2022 | Audible Prompt/Feedback Problem | 1 | Device |
| 2022 | Arcing of Electrodes | 1 | Device |
| 2022 | Accessory Incompatible | 6 | Device |
| 2021 | Failure of Device to Self-Test | 1 | Device |