BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-WAVE DISPOSABLE PRESSURE MONITOR AND VAMP COMBO

    MDR report key: 1021566 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06305
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 9, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED A PROBLEM WITH THE DEVICE, BECAUSE THE TUBING AT THE JUNCTION OF BLOOD RESERVOIR HAS FRACTURED. NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-WAVE DISPOSABLE PRESSURE MONITOR AND VAMP COMBO DISPOSABLE PRESSURE MONITOR W/ BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES PXVMP160 58424128

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK