FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3080837
·
Received April 12, 2013
Report
- Report Number
- 3008642652-2013-00969
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 20, 2013
- Report Date
- April 4, 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING PULSE TESTING WITH ASSOCIATED CODE 203 - PULSE TEST FAULT. THE CAUSE OF THE PULSE TEST FAULT IS INTERMITTENT CONNECTIONS BETWEEN THE COMPUTER / ANALOG (CA) AND DEFIBRILLATOR BOARDS. THE CAUSE OF THE INTERMITTENT CONNECTIONS IS OXIDIZED CONNECTORS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT CONNECTORS. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) FAILED THE INCOMING PULSE TEST WITH ASSOCIATED SERVICE CODE 203. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159804 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |