BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1904084 · Received November 12, 2010

    Report

    Report Number
    2020362-2010-00344
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    September 10, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVAL OF THE PRODUCT FOUND THAT THERE IS EVIDENCE OF MOISTURE ON THE LIQUI-LABEL. THE RJ-11 PINS ARE CORRODED. THE ALARM CASE IS DAMAGED NEAR THE BATTERY COMPARTMENT AND ON THE CORNERS OF THE ALARM CASE. THE BATTERY SPRINGS ARE BENT, ONE SCREW IN THE ALARM CASE IS RUSTED AND THE OTHER IS MISSING. THE ALARM DOES POWER ON AND PASSES ALL FUNCTIONAL TESTS. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT "THE POSEY SITTER SELECT IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES. THERE WAS NO PT INJURY REPORTED. INSPECTION OF THE PRODUCT SHOWS THAT THE ALARM HAS CORROSION ON THE RJ11 PINS.

    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