FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3941547
·
Received April 17, 2014
Report
- Report Number
- 3008642652-2014-01043
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 20, 2014
- Report Date
- April 2, 2014
- 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WOULD NOT SECURELY CONNECT WITH THE MONITOR. THE CAUSE FOR THE INABILITY TO PROPERLY CONNECT WITH THE MONITOR IS A DEFECTIVE TRUNK CABLE CONNECTOR. THE ROOT CAUSE HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) WOULD NOT SECURELY LATCH TO A MONITOR. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236094 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |