BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9607096 · Received January 20, 2020

    Report

    Report Number
    2916596-2020-00137
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    December 30, 2019
    Report Date
    April 7, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER EVENT ON THE MPU WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE MPU WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILE SHOWED 240 EVENTS SPANNING APPROXIMATELY 43 DAYS ((B)(6) 2019 PER TIME STAMP). ON (B)(6) 2019, A NO EXTERNAL POWER EVENT WAS ACTIVE BETWEEN 04:59:56 ¿ 04:59:57 DUE TO A LOSS OF POWER TO THE MPU. THE BACKUP BATTERY PROVIDED POWER TO THE SYSTEM DURING THIS EVENT. THE ALARMS RESOLVED WHEN POWER WAS RESTORED TO THE MPU. PUMP OPERATION WAS NOT AFFECTED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. 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 EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LOG CAPTURED A LOW VOLTAGE/ NO EXTERNAL POWER EVENT ON 12/28 WHILE USING THE MPU. APPEARS THERE WAS A TOTAL LOSS OF POWER TO THE MPU ENABLING THE EBB FOR A SHORT TIME UNTIL POWER WAS RESTORED TO THE MPU. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68255 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention