FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 1864537
·
Received October 1, 2010
Report
- Report Number
- 3002158293-2010-00997
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- August 4, 2010
- Report Date
- October 1, 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: ELECTRODE BELT (B)(4) HAS BEEN EVALUATED. THE REPORTED PROBLEM (ADJUSTED BELT ALARMS) HAS BEEN CONFIRMED. THE CAUSE OF THE ALARMS WAS DUE TO NOISE ON THE FB CHANNEL. UPON INSPECTION, CORROSION WAS FOUND ON THE BACK OF THE ECG D PRINTED CIRCUIT BOARD, CAUSING COMPONENTS U1, V2 AND C3 TO BE DEFECTIVE. THE ROOT CAUSE OF THE CORRODED ECG CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE IS RECEIVING CHECK BELT MESSAGES. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.
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 | 66 YR |