BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDO TUBE INFLATOR & MANOMETER

    MDR report key: 2903133 · Received November 30, 2012

    Report

    Report Number
    2020362-2012-00663
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 12, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    BSK
    PMA / PMN Number
    K912723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: - EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. WHEN PRESSURE IS ATTEMPTED THE NEEDLE MOVES UP ABRUPTLY AND COMES DOWN ON ITS OWN. CUFFLATOR DOES NOT HOLD PRESSURE. THE CUFFLATOR IS MISSING THE BACK COVER AND CLIP. NOTE: THE INSTRUCTIONS FOR USE STATE: THE CUFFLATOR SHOULD BE CALIBRATED ANNUALLY, OR IF MEASUREMENTS ALL OUTSIDE OF A SPECIFIC RANGE, OR IF THE CUFFLATOR NEEDLE DOES NOT INDICATE A READING OF ZERO WHEN NOTHING IS CONNECTED, OR IF THE UNIT IS EVER DROPPED. NEVER OPEN THE CUFFLATOR BODY. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CUFFLATOR WILL NOT HOLD PRESSURE DURING SET-UP. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUFFLATOR ENDO TUBE INFLATOR & MANOMETER BSK J. T. POSEY CO. 8199 1001246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK