FDA Adverse Event Malfunction Summary report: N

SYNCARDIA COMPANION EXTERNAL BATTERY

MDR report key: 3821350 · Received April 28, 2014

Report

Report Number: 3003761017-2014-00060
Event Type: Malfunction
Date Received: April 28, 2014
Date of Event: April 15, 2014
Report Date: April 25, 2014
Manufacturer: SYNCARDIA SYSTEMS, INC.
Product Code: LOZ
PMA / PMN Number: P030011
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION EXTERNAL BATTERIES WERE NOT IN PT USE. IN ADDITION, THIS ALLEGED FAILURE MODE WOULD NOT PREVENT A COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS, BECAUSE THE COMPANION 2 DRIVER HAS MULTIPLE POWER SOURCES: EXTERNAL WALL POWER, EXTERNAL BATTERIES AND AN INTERNAL, EMERGENCY BATTERY. THE COMPANION EXTERNAL BATTERIES WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR. REF REPORT # 3003761017-2014-00083.

Description of Event or Problem · 1

THESE COMPANION EXTERNAL BATTERIES WERE NOT IN USE BY A PT. THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERIES THAT WERE IN STOCK AT THE IMPLANT CENTER WERE "BOTH DEAD." THE CUSTOMER ALSO REPORTED THAT THE COMPANION EXTERNAL BATTERIES HAD BEEN INSTALLED IN A COMPANION 2 DRIVER AT THE IMPLANT CENTER BUT THE DRIVER HAD NOT BEEN PLUGGED INTO EXTERNAL WALL POWER. THE CUSTOMER ALSO REPORTED THAT THE IMPLANT CENTER THEN ATTEMPTED TO CHARGE THE BATTERIES FOR ABOUT A WEEK BUT THE BATTERIES DID NOT CHARGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
254427	SYNCARDIA COMPANION EXTERNAL BATTERY	BATTERY	LOZ	SYNCARDIA SYSTEMS, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1