BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, UK

    MDR report key: 10356877 · Received August 3, 2020

    Report

    Report Number
    2916596-2020-03636
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 15, 2020
    Report Date
    May 6, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MPU MISSING ITS BATTERY COVER WAS NOT CONFIRMED. THE MPU (SERIAL NUMBER (B)(6) WAS NOT RETURNED FOR ANALYSIS. FURTHER DETAILS OF THE MPU¿S PRODUCT RETURN STATUS WERE UNABLE TO BE OBTAINED AFTER MULTIPLE QUESTIONS WERE ASKED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MOBILE POWER UNIT, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MPU WAS SHIPPED TO THE CUSTOMER ON 16SEP2016. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS HOW TO PROPERLY REMOVE AND REATTACH THE MPU¿S BATTERY COMPARTMENT COVER WHEN EXCHANGING THE MPU¿S BATTERIES. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR MPU, AND TO RETURN ANY EQUIPMENT THAT APPEARS DAMAGED OR WORN. USERS ARE ENCOURAGED TO NOT USE ANY EQUIPMENT THAT APPEARS DAMAGED OR WORN. THE HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USER TO CALL THEIR HOSPITAL CONTACTS 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 · 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 THAT DURING SERVICE THE ENGINEER ADVISED THAT THE DEVICE WAS MISSING THE BATTERY COVER. IT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819981 HEARTMATE MOBILE POWER UNIT, UK VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION L107758UK 6242469

    Patients

    Seq Age Sex Outcome Treatment
    1