BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2052099 · Received March 1, 2011

    Report

    Report Number
    1828100-2011-00473
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT THE BATTERY WOULD NOT HOLD A CHARGE AS EXPECTED. UPON UNPLUGGING THE SYSTEM FROM THE WALL POWER SOURCE, A MESSAGE WAS DISPLAYED STATING THAT THERE WERE 188 MINUTES LEFT ON BATTERY POWER; HOWEVER, BATTERY POWER WAS DEPLETED WITHIN 15 MINUTES. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1