FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 2800204
·
Received October 12, 2012
Report
- Report Number
- 3008642652-2012-02714
- Event Type
- Malfunction
- Date Received
- October 12, 2012
- Date of Event
- September 27, 2012
- Report Date
- October 11, 2012
- 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 29 (CHARGE PROFILE FAULT)) HAS BEEN CONFIRMED. CHARGE PROFILE FAULTS INDICATE A NONCONFORMANCE IS PREVENTING THE HIGH VOLTAGE CAPACITORS FROM CHARGING CORRECTLY. THE CAUSE OF THE FAULT WAS IMPROPER SEATING OF THE INTERCONNECT PCA BOARD. THE ROOT CAUSE OF THE IMPROPER SEATING CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE FAULTS. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A GERMAN DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT AN UNK PT'S MONITOR WAS DISPLAYING A SERVICE CODE 29 (CHARGE PROFILE FAULT).
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 | UNK |