BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP SYSTEM WITH ARM-MOUNT RESERVOIR WITH PRESSURE TRANSDUCER

    MDR report key: 2001569 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14910
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, AFTER REPEATED ATTEMPTS TO RETRIEVE THE DEVICE, NO SAMPLE WAS RECEIVED FOR EVALUATION; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE KIT THE TUBING WAS DISCONNECTED. CUSTOMER STATES "THAT IT'S NOT GLUE OR WELDED". "THE TUBING THAT CONNECTS TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAMP SYSTEM WITH ARM-MOUNT RESERVOIR WITH PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXVMP172 58937048

    Patients

    Seq Age Sex Outcome Treatment
    1