FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 3000 SYSTEM

MDR report key: 1872480 · Received October 8, 2010

Report

Report Number: 3002158293-2010-01012
Event Type: Malfunction
Date Received: October 8, 2010
Date of Event: July 29, 2010
Report Date: October 5, 2010
Manufacturer: ZOLL LIFECOR CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT THE PT WAS RECEIVING FALSE ASYSTOLE ALARMS. THE CAUSE OF THE ASYSTOLE ALARMS WAS DUE TO THE BELT CONNECTOR HOUSING BEING CRACKED, NOT ALLOWING THE BELT TO STAY SECURELY CONNECTED WITH THE MONITOR. THE ROOT CAUSE OF THE CRACKED HOUSING WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

Description of Event or Problem · 1

THE NURSE ASSISTING A (B)(6) OLD MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT HAD CALLED THE DOCTOR'S OFFICE STATING THAT THE DEVICE ALARMED "DEVICE DISABLED, CALL AMBULANCE." THE PT'S ELECTRODE BELT WAS REPLACED.

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	49 YR