BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 1914000 · Received November 19, 2010

    Report

    Report Number
    2020362-2010-00361
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    November 3, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS - EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE ALARM POWERED ON AND OFF INTERMITTENTLY. THE BATTERY SPRINGS ARE BENT; HOWEVER, THERE ARE NO LOOSE WIRES. THE BATTERY DOOR IS DAMAGED. THE LIQUID LABEL SHOWS EVIDENCE OF MOISTURE. ONE OF THE ALARM CASE SCREWS SHOWS RUST. THE POSEY INSTRUCTIONS FOR USE HAS A WARNING: THE ALARM IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED (BENT SPRINGS) OR IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT DURING SET-UP TESTING, THE ALARM POWERS ON AND OFF INTERMITTENTLY. CUSTOMER IS USING MAGNET PULL CORD WITH THE ALARM. THE BATTERIES WERE REPLACED WITH ALL OF THE SAME TYPE. THE BATTERY DOOR IS DAMAGED, BUT CLOSES PROPERLY. THE BATTERY CONTACTS ARE SLIGHTLY BENT. THERE WAS NO PATIENT CONTACT 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