BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3190192 · Received June 10, 2013

    Report

    Report Number
    2020362-2013-00261
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 7, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE OF A CONTINUOUS SOUND WHEN IN USE WITH THE SENSOR. THE ALARM HAS NO POWER. HOWEVER, A BATTERY SPRING IS BADLY BENT AND THE UNIT POWERED ON WITH AN EXTERNAL POWER SUPPLY. THE UNIT PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE STATES: HOLD ALARM VERTICALLY UPSIDE DOWN TO PREVENT BATTERY SPRING FROM BENDING DURING BATTERY INSTALLATION. INSERT FOUR (4) NEW "AA" ALKALINE BATTERIES. TAKE CARE NOT TO DAMAGE BATTERY CONTACTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM SOUNDS CONTINUOUSLY WHEN IN USE WITH THE PIR SENSOR. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. CUSTOMER IS NOT SURE IF THE SENSOR IS FUNCTIONING PROPERLY AND DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262136 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PIR SENSOR PART #8351, LOT # E2008240030