BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDOTRACHEAL TUBE CUFF PRESSURE MONITOR

    MDR report key: 2222447 · Received July 13, 2011

    Report

    Report Number
    2020362-2011-00228
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 13, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE CUFFLATORS PRESSURE READINGS BEFORE REPAIRS COULD NOT BE OBTAINED. THE PERFLEX FACE PLATE, RUBBER INFLATION BULB, PLASTIC HOUSING UNIT AND THE RUBBER PROTECTIVE RING WERE REPLACED. THE CUFFLATORS PRESSURE READINGS WERE RECHECKED AND ARE WITHIN SPEC. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CUFFLATOR WILL NOT HOLD PRESSURE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUFFLATOR ENDOTRACHEAL TUBE CUFF PRESSURE MONITOR BSK J. T. POSEY CO. 8199 09076793

    Patients

    Seq Age Sex Outcome Treatment
    1 NI