FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 3190991
·
Received June 21, 2013
Report
- Report Number
- 3008642652-2013-01656
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 18, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL THE ELECTRODE BELT HAD BENT TRUNK CABLE CONNECTOR PINS WHICH PREVENTED THE BELT FROM CONNECTING TO A MONITOR. THE ROOT CAUSE FOR THE BENT PINS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING THE ELECTRODE BELT TO A MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT REC'D A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) HAD BENT TRUNK CABLE CONNECTOR PINS WHICH PREVENTED THE BELT FROM CONNECTING TO A MONITOR. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282327 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |