FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 3904879 · Received June 4, 2014

Report

Report Number: 3008642652-2014-01677
Event Type: Malfunction
Date Received: June 4, 2014
Date of Event: May 1, 2014
Report Date: May 30, 2014
Manufacturer: ZOLL LIFECOR CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER WAS UNABLE TO CHARGER A BATTERY PACK AND WAS RESETTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED Q1 CURRENT - CONTROLLING TRANSISTOR ON THE BEDSIDE BOARD AND CORRUPTED FLASH MEMORY PROGRAMMING. THE ROOT CAUSE FOR THE SHORTED Q1 TRANSISTOR AND THE CORRUPTED PROGRAMMING COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

Description of Event or Problem · 1

A ZOLL PT SERVICE REP (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT WAS RECEIVING BATTERY CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
327991	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL LIFECOR CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR