FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 3173293
·
Received June 7, 2013
Report
- Report Number
- 3008642652-2013-01492
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 31, 2013
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE MONITOR PRODUCED A DISCHARGE PROFILE FAULT. CHARGE PROFILE FAULTS INDICATE THAT THE HIGH VOLTAGE CAPACITORS ARE NOT CHARGING WITHIN THE SPECIFIED TIME PERIOD. THE CAUSE OF THE FAULTS 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 LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING MONITOR SN (B)(4) THE MONITOR PRODUCED A DISCHARGE PROFILE FAULT. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253650 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |