FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3844834
·
Received March 12, 2014
Report
- Report Number
- 3008642652-2014-00789
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 10, 2014
- Report Date
- March 11, 2014
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS REC'D, THE CHARGER/MODEM WOULD NOT POWER ON. UPON EVALUATION, THE POWER SUPPLY UNIT WAS DEFECTIVE. THE CAUSE OF THE INABILITY O POWER ON IS THE DEFECTIVE POWER SUPPLY UNI. THE ROOT CAUSE OF THE DEFECTIVE POWER SUPPLY UNIT CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, CHARGER/MODEM SN (B)(4) WOULD NOT POWER ON. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149294 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOERTER DEFIBRILLATION | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |