BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3062602 · Received March 18, 2013

    Report

    Report Number
    2020362-2013-00125
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 26, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED UNIT COULD NOT CONFIRM THE REPORTED ISSUE BUT FOUND BENT BATTERY SPRINGS. THE CONTACTS INSIDE THE NURSE CALL RECEPTACLE ARE DAMAGED, AS A RESULT THE CABLE WILL NOT GO IN COMPLETELY. DID NOT ATTEMPT TO CONNECT CABLE BY FORCE. SINCE NURSE CALL FUNCTION CANNOT BE UTILIZED, VOICE AND MUTE FUNCTIONS CANNOT BE TESTED. UNIT PASSES ALL OTHER FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE STATE: HOLD ALARM VERTICALLY UPSIDE DOWN TO PREVENT BATTERY SPRING FROM BENDING DURING BATTERY INSTALLATION. INSERT FOUR NEW "AA" ALKALINE BATTERIES. TAKE CARE NOT TO DAMAGE BATTERY CONTACTS. TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. WHEN USING A NURSE CALL CABLE, ENSURE THE NURSE CALL CABLE IS PLUGGED IN TO BOTH THE ALARM AND THE WALL JACK BEFORE LEAVING THE PATIENT UNATTENDED. DO NOT STRETCH OR STRAIN CABLE TO AVOID POSSIBLE DAMAGE AND POSSIBLE MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM SOUNDS CONTINUOUSLY WHEN USED WITH THE NURSE CALL CABLE AND THE PATIENT IS LYING STILL ON THE SENSOR. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111595 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NURSE CALL CABLE: ITEM #8282, LOT #UNK