BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER

    MDR report key: 2860228 · Received November 2, 2012

    Report

    Report Number
    2020362-2012-00638
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 15, 2012
    Manufacturer
    J.T. POWEY COMPANY
    Product Code
    BSK
    PMA / PMN Number
    K912723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE, NEEDLE MOVES UP BUT DOES NOT HOLD PRESSURE. NO READINGS CAN BE TAKEN SINCE THE CUFFLATOR DOES NOT HOLD PRESSURE. RUBBER PROTECTIVE RING HAS CUTS GOING AROUND ITS CIRCUMFERENCE. NOTE: THE INSTRUCTIONS FOR USE STATES: THE CUFFLATOR SHOULD BE CALIBRATED ANNUALLY, OR IF MEASUREMENTS FALL OUTSIDE OF A 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

    THE CUSTOMER REPORTED THE CUFFLATOR DOES NOT HOLD PRESSURE. THE CUSTOMER DID NOT SPECIFY WHAT DATE THE ISSUE WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER BSK J.T. POWEY COMPANY 8199 08026457

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK