BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9466957 · Received December 13, 2019

    Report

    Report Number
    2916596-2019-05868
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 29, 2019
    Report Date
    March 17, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: CORRECTED INFORMATION SECTION H4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS WAS CONFIRMED. THE MPU WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED. THE SUBMITTED LOG FILES CONTAINED APPROXIMATELY 10+ DAYS OF DATA FROM (B)(6)2019 TO (B)(6)2019, PER THE TIMESTAMP. NO EXTERNAL POWER ALARMS ASSOCIATED WITH A LOSS OF AC POWER WHILE THE CONTROLLER WAS CONNECTED TO A MPU WERE RECORDED ON (B)(6)2019 AND (B)(6)2019. NO OTHER ATYPICAL ALARMS WERE RECORDED IN THE REMAINING EVENTS AND THE CONTROLLER OPERATED THE PUMP AT THE SET SPEED THROUGHOUT THE LOG FILE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND THAT (B)(6) WAS MANUFACTURED WITH THE V-LOCK AC CONNECTOR. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P060040; P160054. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER REQUESTED A LOG FILE REVIEW. THE MANUFACTURER TECHNICAL SERVICES REVIEWED THE LOG FILE AND OBSERVED LOW VOLTAGE HAZARD AND NO EXTERNAL POWER EVENTS ON 11/17/ AND 11/24, WHICH ARE DUE TO A TOTAL LOSS OF POWER FROM THE MOBILE POWER UNIT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260779 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization