FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1942906
·
Received December 23, 2010
Report
- Report Number
- 3002158293-2010-01357
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- October 28, 2010
- Report Date
- December 20, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Removal / Correction Number
- 3002158293-10/08/2010-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM HAS BEEN CONFIRMED. THE CAUSE OF THE RESPONSE BUTTONS NOT POWERING ON THE SYSTEM WAS DUE TO A DEFECTIVE FRONT RESPONSE BUTTON. THE CAUSE OF THE DEFECTIVE RESPONSE BUTTON WAS A CRACKED CONDUCTOR ON THE FLEX CIRCUIT TAIL. THE ROOT CAUSE APPEARS TO BE AN ASSEMBLY ERROR. THE FLEX CIRCUIT WAS INADVERTENTLY CREASED BENEATH THE DISPLAY ENCLOSURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) MALE PT, CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT THE MONITOR RESPONSE BUTTONS WERE UNABLE TO ACTIVATE THE DEVICE. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |