BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE UNIVERSAL BATTERY CHARGER

    MDR report key: 10320303 · Received July 24, 2020

    Report

    Report Number
    2916596-2020-03449
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 6, 2020
    Report Date
    October 21, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE UNIVERSAL BATTERY CHARGER (SERIAL#: (B)(6)) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE REPORTED EVENT OF THE UNIVERSAL BATTERY CHARGER (UBC) SMOKING WAS NOT CONFIRMED. THE HEARTMATE UBC (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS TO THE ABBOTT SERVICE DEPOT AND SERVICED. NO LOG FILES WERE SUBMITTED FOR REVIEW. THE UBC WAS FUNCTIONALLY TESTED AND PASSED ALL STAGES OF TESTING. THE UBC POWER SUPPLY PRINTED CIRCUIT BOARD (PCB) WAS EXCHANGED AS A PREVENTATIVE MEASURE AND WAS TESTED FURTHER AT THE ABBOTT POST PRODUCT ENGINEERING LAB. THE UBC PCB WAS PLACED IN A TEST FIXTURE AND WAS ABLE TO CHARGE HEARTMATE 14V BATTERIES FOR AN EXTENDED PERIOD WITHOUT ISSUE. THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED. THE UBC WAS RETURNED TO THE CUSTOMER AFTER THE PCB REPLACEMENT. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED IN THIS ANALYSIS. HEARTMATE II INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. HEARTMATE II INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. HEARTMATE II INSTRUCTIONS FOR USE SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ ADDRESSES HOW TO MINIMIZE THE RISK OF A FIRE HAZARD. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510K: # P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S UNIVERSAL BATTERY CHARGER WAS "SMOKING." EXCHANGE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785121 HEARTMATE UNIVERSAL BATTERY CHARGER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 1440

    Patients

    Seq Age Sex Outcome Treatment
    1