BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2000534 · Received February 24, 2011

    Report

    Report Number
    2015691-2011-14872
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED BECAUSE THE DEVICE WAS DISCARDED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED BY EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. AFTER REVIEW OF THE AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED. IT IS NOT KNOWN IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VAMP FLEX (B)(4) IS IN A NUMBER OF CASES GIVING AN OVERSHOOT OF THE ARTERIAL BLOOD PRESSURE WHILE CONNECTED TO THE PATIENT MONITOR. THIS HAPPENS AFTER THE DPT HAS BEEN ZEROED. THE OVERSHOOT APPEARS AS A LARGE SPIKE ON THE PATIENT MONITOR WHICH RUNS OUT OF THE LIMITS. ADDITIONAL INFORMATION AND CLARIFICATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T005021G UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1