BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER (POCKET SIZE)

    MDR report key: 3012591 · Received February 20, 2013

    Report

    Report Number
    2020362-2013-00086
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 24, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. NOTE: THIS MODEL OF CUFFLATOR IS 3 YEARS OLD. NOTE: THE INFORMATION IN THIS REPORT IS BASED SOLELY ON THE CUSTOMERS INITIAL REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CUFFLATOR WILL NOT HOLD PRESSURE. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74806 CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER (POCKET SIZE) BSK J. T. POSEY CO. 8199P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK