BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9531555 · Received December 30, 2019

    Report

    Report Number
    2916596-2019-05956
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 30, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE INVESTIGATION CONFIRMED THE REPORTED LOW POWER HAZARD ALARMS VIA THE SUBMITTED LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY THIRTEEN HOURS OF DATA ((B)(6) 2019 22:10 ¿ (B)(6) 2019 11:46 PER TIMESTAMP). AT 22:12 WHILE THE BLACK POWER CABLE WAS DISCONNECTED FROM POWER, THE VOLTAGE ON THE WHITE CABLE DROPPED TO ~7.3V THEN TO ~3V IN APPROXIMATELY 2 SECONDS ACTIVATING THE LOW POWER HAZARD ALARMS. THE ALARM CLEARED ONCE POWER WAS RESTORED, THE EVENT LASTED APPROXIMATELY 3 SECONDS, AND APPEAR TO BE RELATED TO A LOSS OF POWER WHILE CONNECTED TO THE MPU. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE OTHER NO EXTERNAL POWER ALARMS WERE RELATED TO THE USER DISCONNECTING BOTH POWER CABLES AT THE SAME TIME. THE MOBILE POWER UNIT WAS NOT RETURNED FOR ANALYSIS AND REMAINS IN USE. ATTEMPTS WERE MADE TO GATHER MORE INFORMATION REGARDING THE REPORTED EVENT, TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED. THE ROOT CAUSE FOR THE LOSS OF AC POWER WHILE THE CONTROLLER WAS CONNECTED TO THE MPU AND SUBSEQUENT LOW POWER HAZARD ALARMS WAS UNABLE TO BE CONCLUSIVELY DETERMINED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. PMA/510(K) #: P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF THE SUBMITTED LOG FILE FOR THE REPORTED NO EXTERNAL POWER ALARMS IT WAS NOTED THAT ONE OF THE OBSERVED LOW POWER HAZARD ALARMS WAS RELATED TO A LOSS OF AC POWER WHILE THE CONTROLLER WAS CONNECTED TO THE MOBILE POWER UNIT MPU. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327128 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR