BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9655885 · Received January 31, 2020

    Report

    Report Number
    2916596-2020-00212
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    January 11, 2020
    Report Date
    April 21, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS WAS CONFIRMED. THE MPU (SERIAL #: (B)(6)) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILE SHOWED EVENTS SPANNING APPROXIMATELY 13 DAYS ((B)(6) 2019 ¿ (B)(6) 2020 PER TIME STAMP). THROUGHOUT THE LOG FILE WHILE CONNECTED TO THE MPU, THERE WERE SEVERAL LOW POWER HAZARD AND NO EXTERNAL POWER EVENTS DUE TO A LOSS OF POWER TO THE MPU. THESE OCCURRED ON (B)(6) 2020 BETWEEN 08:37:56 ¿ 08:39:36 AND ON (B)(6) 2020 BETWEEN 00:53:40 ¿ 00:55:31. THE ALARMS CLEARED THE PATIENT CONNECTED TO BATTERY POWER. THE BACKUP BATTERY PROVIDED POWER TO THE SYSTEM DURING THESE EVENTS. PUMP OPERATION WAS NOT AFFECTED. THE ROOT CAUSE FOR NO EXTERNAL POWER EVENTS WHILE CONNECTED TO THE MPU WAS CONCLUSIVELY DETERMINED TO BE DUE TO POWER OUTAGES CAUSED BY ENVIRONMENTAL FACTORS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR THE PATIENT'S MPU SERIAL NUMBER WERE MADE, HOWEVER, NO RESPONSE WAS SENT BACK. PMA/510(K) #: 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 WENT INTO THE CLINIC WITH NO EXTERNAL POWER EVENTS ON (B)(6) 2020. THIS WAS CAUSED BY POWER TO THE MOBILE POWER UNIT(MPU) BEING BRIEFLY INTERRUPTED. IT WAS REPORTED THAT THE POWER TO THE HOUSE WENT OUT DUE TO A STORM IN THE AREA. THERE HAVE BEEN NO ALARMS REPORTED SINCE THE DATE OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118634 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR