BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3012966 · Received March 1, 2013

    Report

    Report Number
    1828100-2013-00187
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS MAINLY A BACK-UP UNIT THAT HAS ONLY BEEN PLUGGED IN A FEW HOURS AT A TIME WHEN USED FOR A CASE. PER THE FIELD SERVICE REP (FSR), THE SYSTEM SITS IDLE MOST OF THE TIME. HE HAS INFORMED THE USER FACILITY'S BIOMEDICAL ENGINEER THAT THE SYSTEM NEEDS TO BE PLUGGED IN WHEN NOT IN USE SO THE BATTERY STAYS CHARGED.

    Description of Event or Problem · 1

    THE FIELD SERVICE REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE SYSTEM WOULD NOT POWER UP ON BATTERY. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89994 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1