BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1821307 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00184
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    July 27, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALARM, FAILURE TO. RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS INTERMITTENT POWER WHEN USING NEW BATTERIES AND ALSO WHEN USING A POWER SUPPLY. THE ALARM CASE HAS DAMAGE NEAR THE BATTERY COMPARTMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT NO ALARM TONE WHEN THE MAGNET CLIP IS DETACHED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI