BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9503179 · Received December 20, 2019

    Report

    Report Number
    2916596-2019-05991
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 9, 2019
    Report Date
    April 28, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A LOW VOLTAGE ALARM WAS NOT ABLE TO BE REPRODUCED. THE RETURNED MOBILE POWER UNIT SERIAL NUMBER (B)(6) WAS OPERATED FOR EXTENDED PERIOD OF TIME WHILE CONNECTED TO A TEST EQUIPMENT AND THERE WERE NO ADVERSE EVENTS OR ALARMS NOTED. THE REPORTED LOW VOLTAGE ALARM WAS NOT REPRODUCED WHEN TRANSITIONING FROM MPU TO BATTERIES.THE MPU WAS UPGRADED WITH THE NEW SOFTWARE VERSION 1.02. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE MPU PASSED ALL TEST STEPS. THE REPORTED EVENT WAS NOT OBSERVED OR DUPLICATED. THE (B)(6) WAS TESTED AND RETURNED TO THE CUSTOMER SITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED. DEVICE SERIAL NUMBER NOT PROVIDED. PMA/510(K) NUMBER P060040; 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 EXPERIENCED LOW VOLTAGE HAZARD WHILE SWITCHING FROM MOBILE POWER UNIT (MPU) TO BATTERY. THE SITE WAS UNABLE TO CONFIRM IF THE MPU WAS UNPLUGGED FROM THE WALL OR THE AC HOUSING UNIT. THE PATIENT'S MPU WAS SWAPPED OUT. NO FURTHER ALARMS WERE REPORTED POST MPU SWAP. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302172 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR