FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1900080
·
Received November 12, 2010
Report
- Report Number
- 3002158293-2010-01186
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 9, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE CONNECTOR ON THE TRUNK CABLE WAS BROKEN. THE ROOT CAUSE OF THE BROKEN CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING ELECTRODE BELT (B)(4) WAS FOUND TO HAVE A BROKEN CONNECTOR ON THE TRUNK CABLE. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |