BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE INFLATOR AND MANOMETER

    MDR report key: 2982843 · Received January 31, 2013

    Report

    Report Number
    2020362-2013-00041
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 11, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    BSK
    PMA / PMN Number
    K912723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE. INSTEAD FOUND THAT THE FACEPLATE IS CHIPPED BUT NOT MISSING. THE NEEDLE MOVES UP AND THE CUFFLATOR HOLDS PRESSURE AS IT SHOULD. NEEDLE DOES NOT RESET TO ZERO, INSTEAD NEEDLE ONLY RESETS TO 116. INITIALLY, NEEDLE READING WAS AT ZERO. NO READINGS CAN BE TAKEN SINCE NEEDLE DOES NOT RESET TO ZERO. NOTE: INSTRUCTIONS FOR USE STATE: THE CUFFLATOR SHOULD BE CALIBRATED ANNUALLY, OR IF MEASUREMENTS FALL OUTSIDE OF THIS RANGE, OR IF THE CUFFLATOR NEEDLE DOES NOT INDICATE A READING OF ZERO WHEN NOTHING IS CONNECTED, OR IF THE UNIT IS EVER DROPPED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FACEPLATE IS MISSING AND THE NEEDLE IS BROKEN. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42019 ENDOTRACHEAL TUBE INFLATOR AND MANOMETER BSK J. T. POSEY CO. 8199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK