PATIENT MONITORING INSTRUMENT
This device is manufactured by CHATTANOOGA GROUP, MEDTONIC, MEDTRONIC, MEDTRONIC PLC, MICRO THERAPEUTICS DBA EV3 and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Use of Device Problem | 2 | Device |
| 2024 | Unexpected Shutdown | 7 | Device |
| 2024 | Problem with Software Installation | 1 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Overheating of Device | 5 | Device |
| 2024 | Output Problem | 4 | Device |
| 2024 | Operating System Becomes Nonfunctional | 1 | Device |
| 2024 | No Display/Image | 14 | Device |
| 2024 | Moisture Damage | 1 | Device |
| 2024 | Mechanical Problem | 3 | Device |
| 2024 | Material Integrity Problem | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2024 | Impedance Problem | 2 | Device |
| 2024 | Failure to Power Up | 2 | Device |
| 2024 | Failure to Calibrate | 6 | Device |
| 2024 | Electrical Shorting | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 2 | Device |
| 2024 | Display or Visual Feedback Problem | 13 | Device |
| 2024 | Device Difficult to Program or Calibrate | 18 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Corroded | 1 | Device |
| 2024 | Connection Problem | 2 | Device |
| 2024 | Computer Software Problem | 8 | Device |
| 2024 | Computer Operating System Problem | 5 | Device |
| 2024 | Communication or Transmission Problem | 2 | Device |
| 2023 | Shock from Patient Lead(s) | 1 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unexpected Shutdown | 9 | Device |
| 2023 | Problem with Software Installation | 4 | Device |
| 2023 | Power Problem | 4 | Device |
| 2023 | Overheating of Device | 9 | Device |
| 2023 | Output Problem | 11 | Device |
| 2023 | Operating System Becomes Nonfunctional | 3 | Device |
| 2023 | Noise, Audible | 3 | Device |
| 2023 | No Display/Image | 65 | Device |
| 2023 | No Device Output | 1 | Device |
| 2023 | Moisture Damage | 1 | Device |
| 2023 | Mechanical Problem | 9 | Device |
| 2023 | Material Integrity Problem | 3 | Device |
| 2023 | Loose or Intermittent Connection | 2 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | Failure to Power Up | 8 | Device |
| 2023 | Failure to Interrogate | 6 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Failure to Calibrate | 15 | Device |
| 2023 | Electrical Shorting | 1 | Device |
| 2023 | Electrical Power Problem | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 9 | Device |
| 2023 | Display or Visual Feedback Problem | 15 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Device Emits Odor | 1 | Device |
| 2023 | Device Difficult to Program or Calibrate | 69 | Device |
| 2023 | Crack | 2 | Device |
| 2023 | Corroded | 4 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Connection Problem | 3 | Device |
| 2023 | Computer Software Problem | 14 | Device |
| 2023 | Computer Operating System Problem | 19 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Calibration Problem | 5 | Device |
| 2023 | Break | 6 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 10 | Device |
| 2022 | Signal Artifact/Noise | 1 | Device |
| 2022 | Problem with Software Installation | 12 | Device |
| 2022 | Power Problem | 7 | Device |
| 2022 | Overheating of Device | 12 | Device |
| 2022 | Output Problem | 15 | Device |
| 2022 | Operating System Becomes Nonfunctional | 2 | Device |
| 2022 | Noise, Audible | 3 | Device |
| 2022 | No Display/Image | 60 | Device |
| 2022 | No Device Output | 2 | Device |
| 2022 | Moisture Damage | 2 | Device |
| 2022 | Mechanical Problem | 11 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Loose or Intermittent Connection | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Impedance Problem | 2 | Device |
| 2022 | Failure to Power Up | 14 | Device |
| 2022 | Failure to Interrogate | 9 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Failure to Calibrate | 10 | Device |
| 2022 | Electromagnetic Interference | 1 | Device |
| 2022 | Electrical Shorting | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 8 | Device |
| 2022 | Display or Visual Feedback Problem | 2 | Device |
| 2022 | Device Sensing Problem | 3 | Device |
| 2022 | Device Emits Odor | 3 | Device |
| 2022 | Device Difficult to Program or Calibrate | 74 | Device |
| 2022 | Data Problem | 5 | Device |
| 2022 | Corroded | 3 | Device |
| 2022 | Connection Problem | 3 | Device |
| 2022 | Computer Software Problem | 19 | Device |
| 2022 | Computer Operating System Problem | 13 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Communication or Transmission Problem | 3 | Device |
| 2022 | Calibration Problem | 2 | Device |
| 2022 | Break | 7 | Device |
| 2022 | Battery Problem | 2 | Device |
| 2021 | Use of Device Problem | 1 | Device |
| 2021 | Problem with Software Installation | 3 | Device |
| 2021 | Output Problem | 1 | Device |
| 2021 | Noise, Audible | 1 | Device |
| 2021 | No Display/Image | 4 | Device |
| 2021 | Mechanical Problem | 2 | Device |
| 2021 | Failure to Power Up | 2 | Device |
| 2021 | Display or Visual Feedback Problem | 1 | Device |
| 2021 | Device Difficult to Program or Calibrate | 7 | Device |
| 2021 | Computer Software Problem | 1 | Device |
| 2021 | Computer Operating System Problem | 2 | Device |
| 2021 | Break | 1 | Device |
| 2020 | Power Problem | 2 | Device |
| 2020 | Output Problem | 2 | Device |
| 2020 | No Display/Image | 2 | Device |
| 2020 | Failure to Power Up | 1 | Device |
| 2020 | Device Difficult to Program or Calibrate | 1 | Device |
| 2020 | Computer Software Problem | 1 | Device |
| 2020 | Computer Operating System Problem | 1 | Device |