BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9554580 · Received January 6, 2020

    Report

    Report Number
    2916596-2019-06167
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    December 12, 2019
    Report Date
    April 21, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 WAS CONFIRMED WITH THE LOG FILE SUBMITTED ON DECEMBER 13, 2019. THE LOG FILE CAPTURED NO EXTERNAL POWER ALARM EVENTS ON DECEMBER 6. THE SYSTEM WAS CONNECTED TO THE MOBILE POWER UNIT. ACCORDING TO THE VOLTAGE VALUES, THERE WAS A LOSS OF POWER FROM THE MOBILE POWER UNIT DURING EACH EVENT. POWER APPEARED TO HAVE BEEN RESTORED SHORTLY AFTER. ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. 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. PMA/510(K) #:P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NO EXTERNAL POWER EVENT. THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16473 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR