BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2101157 · Received May 24, 2011

    Report

    Report Number
    1056128-2011-00039
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ASCENT
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER FOLLOW-UP WITH THE FACILITY CONFIRMED THE DEVICE WAS NEVER CHECKED TO SEE IF IT WAS PROPERLY INFLATED AND THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE. THE RETURNED DEVICE WAS EXAMINED AND AN INITIAL INSPECTION DID NOT IDENTIFY ANY HOLES, TEARS, PUNCTURES, OR OBVIOUS DEFECTS THAT COULD RESULT IN A POTENTIAL LEAK. FUNCTION TESTING WAS PERFORMED BY TWO DIFFERENT OPERATORS AND THE DEVICE PASSED ALL FUNCTION TESTING. SINCE THE DEVICE PASSED ALL FUNCTION TESTING, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LOT CONTROL SHEET FOR THE DEVICE CONFIRMED THE DEVICE PASSED ALL FUNCTION TESTING BEFORE LEAVING ASCENT. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE NURSE NOTICED BLEEDING AND "BELIEVED THE DEVICE WAS NOT HOLDING THE NECESSARY PRESSURE." THE DEVICE WAS NOT REPLACED AND THERE WAS NO PATIENT INJURY REPORTED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A KCY KCY ASCENT 60-7070-105 1522118

    Patients

    Seq Age Sex Outcome Treatment
    1