BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 10999064 · Received December 13, 2020

    Report

    Report Number
    2916596-2020-05985
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 16, 2020
    Report Date
    June 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Removal / Correction Number
    FA-Q419-MCS-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURES INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT (MPU) NOT POWERING ON WAS CONFIRMED VIA ANALYSIS OF THE RETURNED MPU. THE RETURNED MPU WAS EVALUATED BY SERVICE DEPOT UNDER WORK ORDER 54689752. THE UNIT WOULD NOT POWER ON, REPRODUCING THE REPORTED EVENT. THE MPU POWER SUPPLY PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND THE ISSUE RESOLVED, ISOLATING THE ISSUE TO THE POWER SUPPLY PCB. NO FURTHER TESTING WAS PERFORMED AS THE CUSTOMER REQUESTED FOR THE UNIT TO BE SCRAPPED. THE MPU WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. THE MPU WAS FURTHER EVALUATED BY PPE. EVALUATION OF THE RETURNED MPU REVEALED THAT SEVERAL COMPONENTS ON THE MPU POWER SUPPLY PCB WERE COMPROMISED. DAMAGE TO THESE COMPONENTS WOULD PREVENT THE UNIT FROM POWERING ON AND PROVIDING POWER TO THE SYSTEM CONTROLLER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE MOBILE POWER UNIT (MPU), SERIAL NUMBER MPU-25793, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MPU WAS SHIPPED TO THE CUSTOMER ON 19JUN2017. THE REPORTED EVENT WAS DETERMINED TO BE CAUSED BY DAMAGE TO THE COMPONENTS ON THE MPU POWER SUPPLY; HOWEVER, THE ROOT CAUSE OF THE DAMAGE TO THE COMPONENTS COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS AT HOME AND THE MPU (MOBILE POWER UNIT) FAILED. THE PATIENT WAS ON BATTERIES AND NOT ON THE MPU AT THE TIME. PATIENT WENT INTO THE ROOM AND NOTICED THERE WAS NO GREEN LIGHT ON DESPITE THE UNIT BEING PLUGGED INTO THE WALL. PATIENT TESTED OTHER OUTLETS IN HOME WITH NO SUCCESS. PATIENT WAS GIVEN HOSPITAL LOANER MPU. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464099 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR