BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9532279 · Received December 30, 2019

    Report

    Report Number
    2916596-2019-06124
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 10, 2019
    Report Date
    March 19, 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 MULTIPLE NO EXTERNAL POWER EVENTS WAS CONFIRMED VIA THE PROVIDED LOG FILE. THE LOG FILE CONTAINED DATA SPANNING 3 DAYS ((B)(6) 2019 ¿ (B)(6) 2019 PER TIME STAMP. NO EXTERNAL POWER ALARMS WERE OBSERVED ON (B)(6) 2019 AT 11:37 AND AT 21:44, BOTH WHILE THE MPU WAS IN USE. THE NO EXTERNAL POWER EVENTS APPEARED TO HAVE BEEN CAUSED BY A LOSS OF AC POWER, AS THE RSOC AND VOLTAGE VALUES STEADILY DECREASED OVER 3-4 SECONDS DURING BOTH INSTANCES. THE BACKUP BATTERY OPERATED THE SYSTEM DURING THESE TIMES AND SUPPORT TO THE PUMP WAS NOT INTERRUPTED. BOTH ALARMS RESOLVED WITHIN ONE MINUTE WHEN POWER WAS RESTORED TO THE SYSTEM. NO OTHER EVENTS REGARDING THE MPU WERE OBSERVED THROUGHOUT THE LOG FILE. THE MPU (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THE NO EXTERNAL POWER EVENTS WAS DETERMINED TO BE RELATED TO A LOSS OF AC POWER WHILE THE CONTROLLER WAS CONNECTED TO THE MPU, HOWEVER THE CAUSE FOR THE LOSS OF AC POWER WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE DEVICE SERIAL NUMBER HAVE BEEN MADE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. 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 ROUTINE LOG FILES WERE SENT. DURING THE ANALYSIS OF THE LOG FILES IT WAS OBSERVED THAT THERE WERE MULTIPLE NO EXTERNAL POWER ALARMS WHILE ON THE MOBILE POWER UNIT(MPU). THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THIS MAY BE DUE TO THE POWER CORD COMING LOOSE FROM THE WALL OUTLET OR THE HOUSE LOSING POWER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325023 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR