FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 2974580 · Received January 29, 2013

Report

Report Number: 3008642652-2013-00209
Event Type: Malfunction
Date Received: January 29, 2013
Date of Event: January 5, 2013
Report Date: January 18, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (CHECK THERAPY PAD MESSAGES) HAVE BEEN CONFIRMED. UPON RECEIPT THE ELECTRODE BELT FAILED THE THERAPY ELECTRODE RECOGNITION TEST AND WAS UNABLE TO DELIVER A TREATMENT. THE CAUSE FOR THE TEST FAILURE AND INABILITY TO TREAT WAS AN OPEN BLACK PULSE WIRE IN THE TRUNK CABLE. THE CAUSE FOR THE OPEN PULSE WIRE WAS DAMAGED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR WAS UNABLE TO BE POSITIVELY DETERMINED BUT IS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

Description of Event or Problem · 1

A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING CHECK THERAPY PAD MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
39773	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL LIFECOR CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR