PUMP, INFUSION
This device is manufactured by ALLIED HEALTHCARE PRODUCTS, CARL ZEISS MEDITEC AG, DATASCOPE CORP, GE HEALTHCARE, INSTRUMENTATION LABORATORY CO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Speech Disorder | 1 | Patient |
| 2024 | Paresis | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 4 | Patient |
| 2024 | Insufficient Information | 111 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Dysgeusia | 1 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Ambulation Difficulties | 4 | Patient |
| 2024 | Volume Accuracy Problem | 1 | Device |
| 2024 | Thermal Decomposition of Device | 1 | Device |
| 2024 | Pumping Problem | 2 | Device |
| 2024 | Pressure Problem | 1 | Device |
| 2024 | Power Problem | 2 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | Noise, Audible | 3 | Device |
| 2024 | No Display/Image | 1 | Device |
| 2024 | Mechanical Problem | 9 | Device |
| 2024 | Material Separation | 1 | Device |
| 2024 | Material Integrity Problem | 4 | Device |
| 2024 | Loss of Power | 1 | Device |
| 2024 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2024 | Insufficient Information | 4 | Device |
| 2024 | Infusion or Flow Problem | 1 | Device |
| 2024 | Inaccurate Flow Rate | 1 | Device |
| 2024 | Inaccurate Delivery | 1 | Device |
| 2024 | Image Display Error/Artifact | 1 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Filling Problem | 1 | Device |
| 2024 | False Alarm | 3 | Device |
| 2024 | Failure to Sense | 7 | Device |
| 2024 | Failure to Pump | 1 | Device |
| 2024 | Failure to Prime | 1 | Device |
| 2024 | Failure to Power Up | 1 | Device |
| 2024 | Failure to Infuse | 2 | Device |
| 2024 | Failure to Deliver | 1 | Device |
| 2024 | Failure to Analyze Signal | 1 | Device |
| 2024 | Excess Flow or Over-Infusion | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Sensing Problem | 11 | Device |
| 2024 | Device Emits Odor | 1 | Device |
| 2024 | Device Alarm System | 127 | Device |
| 2024 | Defective Device | 9 | Device |
| 2024 | Defective Component | 7 | Device |
| 2024 | Defective Alarm | 2 | Device |
| 2024 | Data Problem | 2 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Computer Software Problem | 5 | Device |
| 2024 | Computer Operating System Problem | 2 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Circuit Failure | 1 | Device |
| 2024 | Charging Problem | 1 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Blocked Connection | 1 | Device |
| 2024 | Battery Problem | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Speech Disorder | 2 | Patient |
| 2023 | Paresthesia | 1 | Patient |
| 2023 | Paresis | 1 | Patient |
| 2023 | Paralysis | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 3 | Patient |
| 2023 | Movement Disorder | 1 | Patient |
| 2023 | Limb Pain | 1 | Patient |
| 2023 | Ischemia Stroke | 2 | Patient |
| 2023 | Intracranial Hemorrhage | 1 | Patient |
| 2023 | Insufficient Information | 168 | Patient |
| 2023 | Hypoesthesia | 1 | Patient |
| 2023 | Dysgeusia | 1 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Burn(s) | 2 | Patient |
| 2023 | Ambulation Difficulties | 1 | Patient |
| 2023 | Wireless Communication Problem | 5 | Device |
| 2023 | Volume Accuracy Problem | 5 | Device |
| 2023 | Unauthorized Access to Computer System | 1 | Device |
| 2023 | Sparking | 1 | Device |
| 2023 | Problem with Software Installation | 1 | Device |
| 2023 | Power Problem | 6 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Noise, Audible | 6 | Device |
| 2023 | No Display/Image | 7 | Device |
| 2023 | No Audible Alarm | 1 | Device |
| 2023 | Mechanical Problem | 28 | Device |
| 2023 | Material Integrity Problem | 6 | Device |
| 2023 | Loss of Power | 1 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Insufficient Information | 4 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Inaccurate Flow Rate | 2 | Device |
| 2023 | Inaccurate Delivery | 5 | Device |
| 2023 | Image Display Error/Artifact | 1 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | False Alarm | 1 | Device |
| 2023 | Failure to Sense | 3 | Device |
| 2023 | Failure to Read Input Signal | 2 | Device |
| 2023 | Failure to Power Up | 1 | Device |
| 2023 | Failure to Cycle | 1 | Device |
| 2023 | Failure to Analyze Signal | 1 | Device |
| 2023 | Failure of Device to Self-Test | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 2 | Device |
| 2023 | Display or Visual Feedback Problem | 7 | Device |
| 2023 | Device Sensing Problem | 24 | Device |
| 2023 | Device Fell | 1 | Device |
| 2023 | Device Displays Incorrect Message | 3 | Device |
| 2023 | Device Damaged Prior to Use | 1 | Device |
| 2023 | Device Contamination with Body Fluid | 1 | Device |
| 2023 | Device Alarm System | 213 | Device |
| 2023 | Defective Device | 2 | Device |
| 2023 | Defective Component | 3 | Device |
| 2023 | Defective Alarm | 1 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Crack | 4 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Computer Software Problem | 1 | Device |
| 2023 | Computer Operating System Problem | 1 | Device |
| 2023 | Component or Accessory Incompatibility | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Circuit Failure | 5 | Device |
| 2023 | Break | 8 | Device |
| 2023 | Blocked Connection | 1 | Device |
| 2023 | Battery Problem | 11 | Device |
| 2023 | Audible Prompt/Feedback Problem | 2 | Device |
| 2023 | Alarm Not Visible | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2022 | Paresthesia | 1 | Patient |
| 2022 | Movement Disorder | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Wireless Communication Problem | 1 | Device |
| 2022 | Suction Problem | 1 | Device |
| 2022 | Power Problem | 4 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Mechanical Problem | 12 | Device |
| 2022 | Mechanical Jam | 1 | Device |
| 2022 | Low Readings | 1 | Device |
| 2022 | Loss of Data | 1 | Device |
| 2022 | Intermittent Infusion | 2 | Device |
| 2022 | Intermittent Communication Failure | 1 | Device |
| 2022 | Insufficient Information | 4 | Device |
| 2022 | Infusion or Flow Problem | 3 | Device |
| 2022 | Inaccurate Synchronization | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Sense | 1 | Device |
| 2022 | Failure to Cycle | 1 | Device |
| 2022 | Failure of Device to Self-Test | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 4 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Display Difficult to Read | 1 | Device |
| 2022 | Device Sensing Problem | 7 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Displays Incorrect Message | 3 | Device |
| 2022 | Device Damaged Prior to Use | 1 | Device |
| 2022 | Device Alarm System | 103 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Connection Problem | 2 | Device |
| 2022 | Computer Software Problem | 2 | Device |
| 2022 | Computer Operating System Problem | 2 | Device |
| 2022 | Communication or Transmission Problem | 1 | Device |
| 2022 | Circuit Failure | 11 | Device |
| 2022 | Calibration Problem | 1 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Battery Problem | 3 | Device |
| 2022 | Audible Prompt/Feedback Problem | 3 | Device |
| 2022 | Application Program Version or Upgrade Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Noise, Audible | 1 | Device |
| 2020 | Inaccurate Delivery | 1 | Device |