BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 5101677 · Received September 24, 2015

    Report

    Report Number
    3003761017-2015-00311
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERY WOULD NOT CHARGE DESPITE THE BATTERY BEING LEFT IN A COMPANION 2 DRIVER THAT WAS PLUGGED IN OVERNIGHT. THE COMPANION EXTERNAL BATTERY WAS RETURNED TO SYNCARDIA FOR EVALUATION. PHYSICAL INSPECTION OF THE EXTERNAL BATTERY DID NOT REVEAL ANY ANOMALIES. REVIEW OF THE EXTERNAL BATTERY'S SMBUS (SYSTEM MANAGEMENT BUS) DATA WAS REVIEWED AND REVEALED PFIN (PERMANENT FAULT INPUT) FLAG, CIM (CELL IMBALANCE), PUV (PACK UNDER-VOLTAGE) AND CUV (CELL UNDER-VOLTAGE) FLAGS, WHICH INDICATED THAT THE EXTERNAL BATTERY WAS LIKELY SUBJECTED TO A DEEP DISCHARGE EVENT FOLLOWED BY PROLONGED PERIOD OF INACTIVITY. THEREFORE, THE EXTERNAL BATTERY'S INPUT/OUTPUT FUNCTIONS WERE PERMANENTLY DISABLED CONFIRMING THE CUSTOMER-REPORTED ISSUE. THE EXTERNAL BATTERY WAS TAKEN OUT OF SERVICE. THIS FAILURE MODE POSED A LOW RISK TO A PATIENT BECAUSE IT WOULD NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS REDUNDANT, ALTERNATE POWER SOURCES WHICH INCLUDE EXTERNAL WALL POWER AND AN INTERNAL, EMERGENCY BATTERY. IN ADDITION, ALL POWER SOURCES ARE CONTINUALLY MONITORED BY THE COMPANION 2 DRIVER, WITH AUDIBLE AND VISUAL ALARMS PROVIDED TO ANNUNCIATE ANY POTENTIAL ISSUES ASSOCIATED WITH THE DRIVER POWER SOURCES. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERY WOULD NOT CHARGE DESPITE THE BATTERY BEING LEFT IN A COMPANION 2 DRIVER THAT WAS PLUGGED IN OVERNIGHT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. IN ADDITION, IT WOULD NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS A REDUNDANT, ALTERNATE POWER SOURCE OF EXTERNAL WALL POWER. THE COMPANION EXTERNAL BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633022 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1