FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 1872457
·
Received October 8, 2010
Report
- Report Number
- 3002158293-2010-01040
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- September 12, 2010
- Report Date
- October 7, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- 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 (DAMAGED RESPONSE BUTTONS) HAS BEEN CONFIRMED. THE CAUSE OF THE NONFUNCTIONAL RESPONSE BUTTONS WAS PHYSICAL DAMAGE TO THE SWITCHES. THE METALLIC DOMES HAD BEEN PEELED OFF BOTH SWITCHES. THE SOURCE OF THE PHYSICAL DAMAGE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT REC'D A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(4) OLD FEMALE PT CALLED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER RESPONSE BUTTONS WERE DAMAGED. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |