BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL BATTERY

    MDR report key: 11832363 · Received May 17, 2021

    Report

    Report Number
    3003761017-2021-00093
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    March 30, 2021
    Report Date
    July 22, 2021
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED AS THE COMPANION 2 DRIVER DISPLAY SHOWED A RED X OVER THE BATTERY ICON WHEN THE EXTERNAL BATTERY WAS PLACED IN THE DRIVER. DURING EVALUATION, THE EXTERNAL BATTERY WAS NOT ABLE TO CHARGE AND COULD NOT COMMUNICATE WITH THE BATTERY'S SYSTEM MANAGEMENT (SMBUS). THIS INDICATES THAT THE EXTERNAL BATTERY WAS TOO FAR DEPLETED TO BE RECOGNIZED BY THE DRIVER OR ACCEPT A CHARGE. THE ROOT CAUSE WAS MOST LIKELY A DEEP DISCHARGE EVENT LEADING TO A PERMANENT FAULT BY EXTERNAL BATTERY'S INTERNAL SAFETY CIRCUITRY. ALTHOUGH THE CAUSE OF THE DEEP DISCHARGE EVENT COULD NOT BE CONCLUSIVELY DETERMINED, IT IS POSSIBLE THE EXTERNAL BATTERY WAS STORED FOR LONG PERIODS OF TIME WITHOUT CONNECTING TO A POWER SOURCE. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE COMPANION EXTERNAL BATTERY HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE COMPANION EXTERNAL BATTERY WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT COMPANION EXTERNAL BATTERY DID NOT CHARGE IN THE COMPANION 2 DRIVER AND THE DRIVER DISPLAY SHOWED A RED X OVER THE BATTERY ICON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734632 SYNCARDIA COMPANION EXTERNAL BATTERY BATTERY PACK LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1