FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3072327
·
Received April 5, 2013
Report
- Report Number
- 3008642652-2013-00974
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- February 14, 2013
- Report Date
- April 5, 2013
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY - DEVICE EVAL OF MONITOR SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (CODE 102) IS BEING INVESTIGATED. UPON INVESTIGATION THE MONITOR DISPLAYED CODE 102 - CHARGE PROFILE FAULT. A ROOT CAUSE INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.
Description of Event or Problem · 1
THE DOWNLOAD DATA FOR A (B)(6) MALE PT REVEALED SERVICE CODE 102 - CHARGE PROFILE FAULT. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141865 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |