BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-SAT

    MDR report key: 1443253 · Received July 29, 2009

    Report

    Report Number
    1443253
    Event Type
    Malfunction
    Date Received
    July 29, 2009
    Date of Event
    July 28, 2009
    Report Date
    July 29, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT CABLE FAILURE ON PULSE OXIMETER.MANUFACTURER RESPONSE (AS PER REPORTER) FOR PULSE OXIMETER, TRU-SAT:THEY FEEL THAT THE CABLES MEET OR EXCEED THE EXPECTED LIFE SPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-SAT PULSE OXIMETER DQA GE MEDICAL SYSTEMS, LLC OXY-MC3 21408 AND 15907

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR