BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9700481 · Received February 12, 2020

    Report

    Report Number
    2916596-2020-00522
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    July 16, 2018
    Report Date
    April 21, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM REGARDING THE MOBILE POWER UNIT (MPU) WAS CONFIRMED VIA THE LOG FILES. THE TWO REVIEWED LOG FILES CONTAINED DATA THAT COLLECTIVELY SPANNED 10 DAYS (B)(6) 2018 ¿ (B)(6) 2018 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LSL (LOWER SPEED LIMIT) WHILE CONNECTED TO THE DRIVELINE. A NO EXTERNAL POWER EVENT OCCURRED ON (B)(6) 2018 AT 5:53 WHILE THE PATIENT WAS CONNECTED TO AN MPU. THE EVENT APPEARED TO HAVE BEEN CAUSED BY A LOSS OF AC POWER, AS THE RSOC STEADILY DECREASED. THE ALARM RESOLVED WHEN THE PATIENT CONNECTED TO BATTERY POWER. NO OTHER NOTABLE EVENTS RELATED TO THE MPU WERE OBSERVED THROUGHOUT THE LOG FILE. THE MPU (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS AT RETRIEVING INFORMATION ABOUT THE CAUSE OF THE NO EXTERNAL POWER EVENT WERE MADE, AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE LOSS OF AC POWER OBSERVED WITHIN THE DATA WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NO EXTERNAL POWER ALARM ON THE MOBILE POWER UNIT (MPU) WAS OBSERVED WITHIN THE PROVIDED LOG FILE, CORRELATING TO A LOSS OF AC POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163454 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR