FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 2911213 · Received December 14, 2012

Report

Report Number: 3008642652-2012-03296
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: November 29, 2012
Report Date: December 12, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT 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 THE C/A BOARD, SN (B)(4). THE FLASH MEMORY HAD AN INTERMITTENT CONNECTION. 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 SUBMITTED FOR FDA REVIEW WON (B)(4) 2012 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT MONITOR.

Description of Event or Problem · 1

A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WAS NOT POWERING UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR