BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICLE MODULE II

    MDR report key: 1113303 · Received August 11, 2008

    Report

    Report Number
    6000002-2008-08376
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: OM2 FAILED SVO2 INCORRECT- DRIFT. DEVICE RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, CABLE NOT WORKING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICLE MODULE II OPTICAL MODULE/OXIMETRY CABLE DXG EDWARDS LIFESCIENCES OM2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK