BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2434885 · Received January 26, 2012

    Report

    Report Number
    2020362-2012-00044
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Report Date
    December 27, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THERE WAS INTERMITTENCY IN POWER WHEN THE ALARM WAS TESTED. THERE IS ONE BATTERY SPRING INSIDE THE BATTERY COMPARTMENT THAT IS BENT. THE MOISTURE INDICATOR LABEL IS MISSING. NOTE: INSTRUCTIONS FOR USE STATE: 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. STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF; BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE IS CRACKED. WHEN ACCESSING THE BATTERY COMPARTMENT SLIDE BATTERY DOOR OPEN AND FLIP IT UP. DO NOT ATTEMPT TO REMOVE BATTERY DOOR; IT DOES NOT SEPARATE FROM ALARM. CAREFULLY REMOVE BATTERIES TO AVOID DAMAGE TO BATTERY DOOR. INSERT FOUR (4) NEW "AA" ALKALINE BATTERIES. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER. THE CUSTOMER REPORTED THAT ONE BATTERY CONTACT LOOKS A LITTLE FLAT. 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 OVER MATTRESS SENSOR PAD: MODEL 8307, LOT # UNK