BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDO TUBE INFLATOR & MANOMETER

    MDR report key: 2903084 · Received November 30, 2012

    Report

    Report Number
    2020362-2012-00662
    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
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS ¿ EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. WHEN PRESSURE IS ATTEMPTED ON THE CUFFLATOR THE NEEDLE MOVES UP BUT COMES DOWN SLOWLY ON ITS OWN. THE NEEDLE SITS -2CM BELOW ZERO ON THE DIAL. NO PHYSICAL DAMAGES TO THE UNIT FOUND. 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 DOES 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 02152319

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK