BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER

    MDR report key: 3012593 · Received February 20, 2013

    Report

    Report Number
    2020362-2013-00087
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    February 1, 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
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE THE NEEDLE DOES NOT RETURN TO ZERO WHEN INFLATED, IT WILL ONLY RETURN TO 60 MMHG. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CUFFLATOR HAS AN UNSTABLE POINTER THAT WILL NOT GO TO ZERO ON THE DIAL. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74807 CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER BSK J. T. POSEY CO. 8199 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA