BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER VAMP COMBO

    MDR report key: 1112515 · Received August 8, 2008

    Report

    Report Number
    6000002-2008-08300
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Product Code
    DRS
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    LINE DETACHMENT AT VAMP RESERVOIR SOLVENT BOND BETWEEN RESERVOIR BODY AND SHUT OFF VALVE OF RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER VAMP COMBO DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS T431305A 127C0155

    Patients

    Seq Age Sex Outcome Treatment
    1