BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 10071091 · Received May 19, 2020

    Report

    Report Number
    2916596-2020-02652
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    December 7, 2019
    Report Date
    July 15, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER REQUESTED BUT NOT PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF A NO EXTERNAL POWER ALARM COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO RELEVANT LOG FILES WERE SUBMITTED FOR REVIEW. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK PROVIDE INFORMATION ON ALL SYSTEM ALARMS, INCLUDING THE NO EXTERNAL POWER ALARM, AND THE APPROPRIATE ACTIONS NECESSARY TO RESOLVE THEM. THE PATIENT HANDBOOK ALSO PROVIDES CHECKLISTS INVOLVED IN ROUTINE MAINTENANCE, INCLUDING INSPECTING THE SYSTEM CONTROLLER AND MPU POWER CABLES FOR DAMAGE. BOTH DOCUMENTS INSTRUCT THE USER TO CALL THEIR HOSPITAL CONTACT IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION G2: CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR DEVICE SERIAL NUMBER WERE MADE, HOWEVER, NO RESPONSE WAS RECEIVED. PMA/510K: P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NO EXTERNAL POWER ALARM ON (B)(6) 2019 AT 11:00PM. PATIENT DOES NOT RECALL IF SHE DISCONNECTED BOTH POWER CABLES AT THE SAME TIME OR IF SHE WAS CONNECTED TO THE MOBILE POWER UNIT (MPU) UNIT. SHE REPORTS THAT SHE DID NOT LOOSE POWER IN HER HOME BUT IS USUALLY CONNECTED TO MPU BY THAT TIME. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534516 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization