BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPP-100C BATTERY 12V-2.3AH

    MDR report key: 5297533 · Received December 15, 2015

    Report

    Report Number
    5297533
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    August 27, 2014
    Report Date
    November 12, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WENT TO HAVE A SCOPE COMPLETED. WHEN HE CAME BACK, HIS VASCULAR ACCESS DEVICE (VAD) DISPLAY MODULE CORD WAS COMPLETELY BROKEN, LIKE THE CORD HAD BEEN RIPPED APART. THE POWER BASE MODULE WAS ALSO OUT OF BATTERY, WHICH WOULD MEAN THAT IT WAS NOT PLUGGED INTO A POWER SOURCE DURING HIS PROCEDURE. THIS IS A PATIENT SAFETY ISSUE BECAUSE IF THE POWER BASE RUNS OUT OF BATTERY WHEN THE PATIENT IS CONNECTED, THE VAD WILL NOT HAVE A POWER SOURCE. THE PATIENT'S POWER BASE ALARMED SO HE CONNECTED TO BATTERY POWER AND HE WAS NOT HARMED. PATIENT WILL NEED A NEW DISPLAY MODULE AND BATTERY FOR THE POWER BASE UNIT. THE VAD COORDINATORS WERE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827512 EPP-100C BATTERY 12V-2.3AH VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION EPP-100C MN213444

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR