BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT

    MDR report key: 1013226 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06152
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 27, 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 BEEN RECEIVED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL RUBBER OF THE SYRINGE UNFASTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT DISPOSABLE PRESSURE MONITOR AND BLOOD SAMPLING KIT DRS EDWARDS LIFESCIENCES PXVP2260 58444021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN