FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 2961437 · Received January 18, 2013

Report

Report Number: 3008642652-2013-00181
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: December 25, 2012
Report Date: January 16, 2013
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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON C/A BOARD 52025843. THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION AT PIN A25. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. IMPLEMENTATION IS PLANNED FOR 02/04/2013, BASED ON THE AVAILABILITY OF PARTS AND MATERIALS. RESULTS WILL BE MONITORED. NO ADVERSE EVENTS RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

Description of Event or Problem · 1

A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27754	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL LIFECOR CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR