FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 1961502
·
Received January 10, 2011
Report
- Report Number
- 3002158293-2011-00005
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 11, 2010
- Report Date
- January 6, 2011
- 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. DURING SERVICE EVAL, IT WAS FOUND THAT THE END CAP WAS SEPARATED FROM THE MONITOR CASE AND THE WHITE CABLES RUNNING FROM THE COMPUTER/ANALOG PCA BOARD TO THE AUXILIARY BOARD WERE UNPLUGGED. THE ROOT CAUSE FOR THE END CAP SEPARATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS PROBABLY THE RESULT OF A DROP OR EXCESSIVE FORCE. THE CABLES WERE RECONNECTED AND THE MONITOR WAS THEN FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. AS RECEIVED, MONITOR SN (B)(4) HAD CRACKED CASING THAT WAS SEPARATING ALONG THE SEAMS. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |