BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 2241317 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00307
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY STATEMENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DID NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE CUSTOMER DISCONNECTED THE SENSOR FROM THE ALARM AND THE ALARM DID NOT SOUND. THE SENSOR CHECKED IS NEW AND FREE OF CREASES OR FOLDS. THE BATTERIES WERE REPLACED AND THERE IS NO VISIBLE DAMAGE TO THE ALARM REPORTED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA