BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    MDR report key: 5993547 · Received October 3, 2016

    Report

    Report Number
    3003761017-2016-00339
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT SINCE THE DRAINED BATTERY DID 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 AND BACKUP EXTERNAL BATTERIES. THE COMPANION EXTERNAL BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) (2 OF 2).

    Additional Manufacturer Narrative · 1

    THE COMPANION EXTERNAL BATTERY WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE SYSTEM MANAGEMENT BUS (SMBUS) DATA WAS REVIEWED AND REVEALED NO ANOMALOUS BEHAVIOR OR VALUES. THE REPORTED LOW CAPACITY CONDITION COULD NOT BE DUPLICATED OR CONFIRMED. THE EXTERNAL BATTERY WAS TESTED, INCLUDING BATTERY DISCHARGE, AND EVALUATION DETERMINED THAT THE EXTERNAL BATTERY FUNCTIONED AS INTENDED WITH NO EVIDENCE OF A DEVICE MALFUNCTION. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1 (2 OF 2).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERY LOST ITS CHARGE AFTER 15 MINUTES WHILE IN A COMPANION 2 DRIVER SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT A SUBSEQUENT TEST REVEALED THE COMPANION EXTERNAL BATTERY LOST ITS CHARGE AFTER 30 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERY LOST ITS CHARGE AFTER 15 MINUTES WHILE IN A COMPANION 2 DRIVER SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT A SUBSEQUENT TEST REVEALED THE COMPANION EXTERNAL BATTERY LOST ITS CHARGE AFTER 30 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644635 SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK BATTERY PACK LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR