FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2800140
·
Received October 12, 2012
Report
- Report Number
- 3008642652-2012-02713
- Event Type
- Malfunction
- Date Received
- October 12, 2012
- Date of Event
- September 20, 2012
- Report Date
- October 10, 2012
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT TRUNK CABLE CONNECTOR WAS CRACKED, AND THE RED (CAN H) WIRE INSIDE OF THE CONNECTOR WAS OPEN. THE ROOT CAUSE FOR THE BROKEN CONNECTOR AND BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR AND WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
DOWNLOAD DATA FROM A (B)(6) MALE PATIENT REVEALED SEVERAL OCCURRENCES OF SERVICE CODE 204. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND ISSUED HIM A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |