FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3983533
·
Received June 26, 2014
Report
- Report Number
- 3008642652-2014-01978
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 10, 2014
- Report Date
- June 25, 2014
- Manufacturer
- ZOLL MANUFACTURING 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. UPON RECEIPT THE ELECTRODE BELT FAILED INCOMING FUNCTIONAL TESTING. THE CAUSE FOR THE TEST FAILURE AS A DEFECTIVE ESD700 (6 LINE ESD PROTECTION DIODE ARRAY) COMPONENT IN THE ELECTRODE BELT DISTRIBUTION NODE. ESD700 WAS INTERNALLY SHORTED. THE ROOT CAUSE FOR THE DEFECTIVE COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT OCCURRED DUE TO THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
WHILE EVALUATING A (B)(6) FEMALE PATIENT'S ELECTRODE BELT FOR AN UNRELATED ISSUES, A REPORTABLE PROBLEM WAS FOUND. THE ELECTRODE BELT FAILED INCOMING FUNCTIONAL TESTING. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373962 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |