BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3180137 · Received June 4, 2013

    Report

    Report Number
    2020362-2013-00245
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Report Date
    May 9, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE. THE ALARM DOES NOT SHUT OFF WHEN THE VOLUME IS CHANGED. HOWEVER, A BATTERY SPRING IS BADLY BENT AND THERE IS BATTERY LEAKAGE AND CORROSION ON A BATTERY SPRING. UNIT POWERS UP AND SOUNDS AS IT SHOULD AND UNIT PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE STATE: 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. BATTERIES CAN EXPLODE OR LEAK AND CAUSE DAMAGE TO ALARM IF INSTALLED INCORRECTLY, FULLY DISCHARGED, OR EXPOSED TO LIQUID, FIRE OR HIGH TEMPERATURES. IF BATTERY DAMAGE HAS OCCURRED, OR YOU SEE ANY CORROSION, REMOVE THE ALARM FROM USE IMMEDIATELY. DO NOT USE THE ALARM IF BATTERY DAMAGE HAS BEEN DETECTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE VOLUME TO THE ALARM IS TURNED DOWN THE ALARM SHUTS OFF. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247639 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER MATTRESS SENSOR PART # 8307: LOT # UNK