FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2844823
·
Received November 2, 2012
Report
- Report Number
- 3008642652-2012-02922
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- September 3, 2012
- Report Date
- November 1, 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK ELECTRODE BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING ECG "A" AND ECG "B" WAS CUT, WHICH CAUSED SIGNAL DISTORTION WHEN THE CABLE WAS MANIPULATED. THE SIGNAL DISTORTION CAUSE THE CHECK ELECTRODE BELT ALARMS. THE ROOT CAUSE FOR THE CUT CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED ROM THE DAMAGED CABLE.
Description of Event or Problem · 1
A EUROPEAN DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT AN ELECTRODE BELT WAS CAUSING CHECK BELT MESSAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |