FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2160496
·
Received July 1, 2011
Report
- Report Number
- 3008642652-2011-00134
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- May 10, 2011
- Report Date
- July 1, 2011
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE TRUNK CABLE AND CONNECTOR WERE DAMAGED. THE CAUSE FOR THE DAMAGED CABLE AND CONNECTOR CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR AND CABLE.
Description of Event or Problem · 1
A (B)(4) DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) FOR AN UNRELATED COMPLAINT. DURING SERVICING, A REPORTABLE EVENT WAS REVEALED. THE ELECTRODE BELT'S TRUNK CABLE AND CONNECTOR WERE DAMAGED.
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 | NA |