BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, UK

    MDR report key: 9806406 · Received March 9, 2020

    Report

    Report Number
    2916596-2020-00977
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 18, 2020
    Report Date
    July 31, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED WITH THE DATA CAPTURED IN THE SUBMITTED LOG FILE. THE LOG FILE CAPTURED NO EXTERNAL POWER ALARM EVENT ON FEBRUARY 18 AT 8:17 AM. ACCORDING TO THE VOLTAGE VALUES, THE BLACK POWER CABLE WAS DISCONNECTED FROM THE MOBILE POWER UNIT, WHICH WAS FOLLOWED WITH THE DISCONNECTION OF THE WHITE POWER CABLE. THIS APPEARS TO BE RELATED TO A DOUBLE DISCONNECTION, WHICH RESULTED IN THE NO EXTERNAL POWER ALARM TO BECOME ACTIVE. THE SYSTEM REVERTED TO THE BACKUP BATTERY FOR POWER. SHORTLY AFTER, 14V BATTERIES WERE CONNECTED TO BOTH POWER CABLES AND ALL ALARMS CLEARED. ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT. TO DATE, THE SYSTEM CONTROLLER (SERIAL # (B)(6)) ASSOCIATED WITH THE EVENT WAS UNAVAILABLE FOR AN EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON THE DEVICE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON THE DEVICE. 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 LOG FILES SHOWED MULTIPLE NO EXTERNAL POWER ALARMS WHILE THE PATIENT WAS USING THE MOBILE POWER UNIT. THE ALARMS WERE REPORTEDLY DUE TO ELECTROSTATIC DISCHARGE FROM A BLANKET THE PATIENT WAS USING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268582 HEARTMATE MOBILE POWER UNIT, UK VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531INT 6533731

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR