BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3866577 · Received April 25, 2014

    Report

    Report Number
    2020362-2014-00161
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    March 24, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. THIS REPORT IS MADE BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. NOTE: INSTRUCTIONS FOR USE STATE: FACILITY FALL MANAGEMENT POLICY SHOULD ADDRESS THE FREQUENCY OF VISITS BY NURSING STAFF TO: CONFIRM PATIENT IS SAFE. ATTEND TO PATIENT NEEDS FOR NUTRITION, TOILETING, EXERCISE, AND THERAPY. CHECK ALARM FUNCTION EVERY TIME BEFORE LEAVING PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPER FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, THE PIR SENSOR IS ACTIVATED, OR MAGNET IS REMOVED FROM FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM SOUNDS INTERMITTENTLY. WHEN THE ALARM IS IN ONE POSITION IT SOUNDS AS IT SHOULD, BUT WHEN IT IS IN A DIFFERENT POSITION IT DOES NOT SOUND. CUSTOMER REPORTED THIS WAS DISCOVERED DURING SET UP WHILE CAREGIVER STILL AT BEDSIDE BUT COULD NOT PROVIDE A DATE. NO PHYSICAL DAMAGES SEEN ON THE ALARM UNIT. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250598 SITTER SELECT KMI J. T. POSEY COMPANY 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER-THE-MATTRESS SENSOR PAD: MODEL: 8307 LOT #UNK