BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3253637 · Received July 17, 2013

    Report

    Report Number
    2020362-2013-00314
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 19, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL, BUT HAS NOT BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY REPORTED ISSUE. NOTE: IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY 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 HAS POWER, BUT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. CUSTOMER DID NOT KNOW THE DATE WHEN THE ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331801 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BED SENSOR PAD: MODEL 8307, LOT # UNK