BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9563586 · Received January 8, 2020

    Report

    Report Number
    2916596-2019-06087
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 9, 2019
    Report Date
    May 28, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    SECTION H4: ADDITIONAL INFORMATION MANUFACTURER'S ANALYSIS CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER EVENT DUE TO THE POWER CORD BEING UNPLUGGED FROM THE WALL WAS NOT ABLE TO BE DETERMINED. LOG FILES (EVENT AND PERIODIC) PROVIDED BY THE CUSTOMER WERE REVIEWED. THE EVENT LOG FILE CONTAINED EVENTS RECORDED FROM (B)(6) TO (B)(6) 2019 WHERE PI EVENTS WERE RECORDED. THE LOG FILE DID NOT CONTAIN ANY NO EXTERNAL POWER EVENTS. THE PERIODIC LOG FILE RECORDED EVENTS FROM (B)(6) TO (B)(6) 2019. THERE WERE NO ALARMS/EVENTS CAPTURED IN THE LOG FILE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REMAINED IN USE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT EXPERIENCED A NO EXTERNAL POWER EVENT WHILE SUPPORTED BY THE MOBILE POWER UNIT (MPU). LOG FILE ANALYSIS COULD NOT CONFIRM THE NO EXTERNAL POWER EVENTS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29411 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR