BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH VAMP

    MDR report key: 1891990 · Received November 6, 2010

    Report

    Report Number
    2015691-2010-14332
    Event Type
    Malfunction
    Date Received
    November 6, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE BECAME DISCONNETED FROM WHERE IT PLUGS INTO THE VAMP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH VAMP DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES PR VAMPUNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1