FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 3000 SYSTEM

MDR report key: 2920641 · Received December 7, 2012

Report

Report Number: 3008642652-2012-03248
Event Type: Malfunction
Date Received: December 7, 2012
Date of Event: November 21, 2012
Report Date: December 6, 2012
Manufacturer: ZOLL LIFECOR CORP
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 BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT PROPERLY CHARGE BATTERIES) HAS BEEN CONFIRMED. UPON RECEIPT, THE CHARGER WAS INTERMITTENT. THE CAUSE OF THE INABILITY TO PROPERLY CHARGER THE BATTERIES IS AN INTERMITTENT CHARGER. THE CAUSE OF THE INTERMITTENT CHARGER IS A DEFECTIVE POWER UNIT. THE CAUSE OF THE DEFECTIVE POWER UNIT IS DISCONNECTED PINS IN THE CONNECTOR. THE ROOT CAUSE FOR THE DISCONNECTED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER UNIT. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

Description of Event or Problem · 1

A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS NOT PROPERLY CHARGING THE BATTERIES. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFEVEST WCD 3000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL LIFECOR CORP	WCD 3000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR