BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9586632 · Received January 14, 2020

    Report

    Report Number
    2916596-2020-00096
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 16, 2019
    Report Date
    May 22, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED VIA THE PROVIDED LOG FILE. THE PROVIDED LOG FILE CONTAINED DATA SPANNING 12 DAYS (B)(6) 2019 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. NO EXTERNAL POWER ALARMS WERE OBSERVED TO BECOME INTERMITTENTLY ACTIVE ON (B)(6) 2019, FROM 1:49 ¿ 4:09, ALL WHILE THE MPU WAS IN USE. THE ALARMS APPEARED TO HAVE BEEN CAUSED BY LOSSES OF AC POWER, AS THE RSOC VALUES STEADILY DECREASED OVER A FEW SECONDS IN EVERY INSTANCE. THE BACKUP BATTERY APPROPRIATELY OPERATED THE SYSTEM DURING THESE TIMES. NO OTHER NOTABLE EVENTS REGARDING THE MPU WERE OBSERVED THROUGHOUT THE LOG FILE. THE MPU (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS AT RETRIEVING INFORMATION ABOUT THE CAUSE OF THE NO EXTERNAL POWER EVENTS WERE MADE, AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE LOSSES TO AC POWER OBSERVED THROUGHOUT THE LOG FILE WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. 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 ON (B)(6) 2019 WE NOTED NO EXTERNAL POWER ALARMS WHILE ON THE MPU. THIS CAN BE CAUSED BY THE POWER CORD COMING LOOSE FROM THE MPU, THE WALL OUTLET, OR THE PATIENT LOSING POWER IN THE HOUSE. IF THE PATIENT DOES NOT HAVE A LOCKING POWER CORD, IT IS RECOMMENDED YOU CONTACT YOUR CLINICAL SPECIALIST TO ASSIST IN ORDERING ONE. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51852 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention