BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9539327 · Received January 2, 2020

    Report

    Report Number
    2916596-2019-05944
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 4, 2019
    Report Date
    March 13, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVENT, OF NO EXTERNAL POWER ALARMS ASSOCIATED WITH THE MPU, WAS CONFIRMED IN THE SUBMITTED LOG FILE. THE CUSTOMER SUBMITTED HEARTMATE 3 LVAS LOG FILES FOR REVIEW NOTING ALARMS WHILE THE PATIENT WAS USING THE MPU. TECHNICAL SERVICE REVIEWED THE LOG FILES AND NOTED THE LOSS OF EXTERNAL POWER EVENTS. THE EVENT LOG FILE CONTAINED APPROXIMATELY 7 DAYS OF PATIENT EVENT DATA. THERE WERE TWO LOSS OF POWER EVENTS THAT OCCURRED WITH THE PATIENT ON THE MPU. THE FIRST OCCURRED ON (B)(6) 2019 03:14:05 AND RESOLVED WITHIN 7 SECONDS; THE SECOND OCCURRED A FEW HOURS LATER AT 05:11:41 AND RESOLVED WITHIN 21 SECONDS. THE BATTERY CAPACITY (RSOC) INDICATORS AND CABLE VOLTAGES CORRESPONDED TO A LOSS OF MPU AC POWER. THE MPU WAS THE POWER SOURCE BEFORE AND AFTER EACH EVENT. THE CONTROLLER OPERATED ON BACKUP BATTERY POWER DUE TO THE EVENTS. NO PRODUCT WAS RETURNED FOR EVALUATION. THE CUSTOMER NOTED THAT THE PATIENT WAS USING THE LOCKING AC POWER CORD AND WAS NOT AWARE OF ANY POWER CORD DISCONNECTIONS OR LOSS OF AC POWER OCCURRENCES. THE REASON FOR THE LOSS OF EXTERNAL POWER EVENTS COULD NOT BE DETERMINED FROM THE SUBMITTED LOG FILE. 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 LOW VOLTAGE LEADING TO A POWER CABLE DISCONNECT WAS OBSERVED WHILE UTILIZING A MOBILE POWER UNIT. IT WAS REPORTED THAT THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR