FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2823723
·
Received October 10, 2012
Report
- Report Number
- 3008642652-2012-02710
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- June 14, 2012
- Report Date
- October 10, 2012
- Manufacturer
- ZOLL LIFECOR CORP
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 110 - OVER VOLTAGE CLEARED NO ENERGY) WAS CONFIRMED. UPON INVESTIGATION, L1 (SMD POWER INDUCTOR) WAS OPEN. THE OPEN INDUCTOR PREVENTED VOLTAGE FROM REACHING THE CONVERTER CIRCUIT ON THE MONITOR'S COMPUTER/ANALOG BOARD. THIS CAUSED THE CODE 110 TO BE DISPLAYED. THE ROOT CAUSE OF THE OPEN L1 INDUCTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A MONITOR WAS DISPLAYING A SERVICE CODE. THE DISTRIBUTOR WAS ISSUED 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 CORP | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |