BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2462933 · Received February 3, 2012

    Report

    Report Number
    2020362-2012-00059
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    January 6, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE ALARM POWERS ON, HOWEVER THE NURSE CALL LIGHT DID NOT LIGHT UP. THERE IS A SMALL CRACK ON THE TOP LEFT CORNER AND THE BATTERY DOOR IS HARD TO OPEN. THE RJ11 RECEPTACLE PLASTIC PIECE IS DAMAGED. NOTE: INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: 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. REMOVE ALARM FROM USE IF IT FAILS TO WORK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE NURSE CALL CABLE IS USED WITH THE ALARM AND WEIGHT IS REMOVED FROM THE SENSOR THE ALARM DOES NOT SEND NOTICE AT THE NURSE CALL STATION. THERE WAS NO PT INCIDENT OR 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 THE MATTRESS SENSOR PAD: MODEL 8307, LOT # NI