BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9728754 · Received February 19, 2020

    Report

    Report Number
    2916596-2020-00509
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 27, 2020
    Report Date
    April 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MPU IS NOT FUNCTIONING PROPERLY WAS CONFIRMED DURING ANALYSIS. THE EVALUATION OF THE RETURNED MOBILE POWER UNIT SERIAL NUMBER (B)(6) REVEALED A COMPROMISED MAIN PCB COMPONENT. AS A RESULT THE USER INTERFACE (GREEN POWER, YELLOW WRENCH, YELLOW BATTERY LEDS) AND THE SPEAKERS WERE NOT ACTIVE. THE MPU WAS STILL ABLE TO SUPPLY POWER WHEN CONNECTED TO A TEST SYSTEM CONTROLLER AND PUMP AND THE SYSTEM OPERATED WITH NO ACTIVE ALARMS. THE MAIN PCB WAS REPLACED AND THE ISSUE WAS RESOLVED. THE MPU WAS FUNCTIONALLY TESTED AND PASSED ALL TEST STEPS. THE DEVICE WAS RETURNED TO THE CUSTOMER. HEARTMATE II PATIENT HANDBOOK, MPU WITH CD, SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, ADDRESSES ALL ALARM CONDITIONS INCLUDING NO EXTERNAL POWER ALARMS. SECTION 3 OF THE PATIENT HANDBOOK, ENTITLED ¿POWERING THE SYSTEM¿, OUTLINES THE USE OF THE MPU INCLUDING HOW TO CONNECT THE MPU TO POWER AND THE LIGHTS THAT ARE ACTIVE WHEN THE MPU IS POWERED ON AND FUNCTIONING PROPERLY. THE PATIENT HANDBOOK ALSO CAUTIONS THE USERS 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

    PMA/510(K)#: P060040; 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 THAT THE MOBILE POWER UNIT (MPU) KEPT LOOSING POWER. MULTIPLE OUTLETS WERE TRIED AND ALSO TRIED SWITCHING THE BATTERIES OUT ON THE ACTUAL MPU TO NO AVAILABLE. THE PATIENT HAD BEEN USING BATTERIES AND WAS INSTRUCTED TO CONTINUE TO DO SO UNTIL THEY RECEIVE THE LOANER FROM ABBOTT. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188909 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention