BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3000096 · Received February 8, 2013

    Report

    Report Number
    2020362-2013-00056
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. INSTRUCTIONS FOR USE STATE: TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. 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. ENSURE THE GREEN LED, INDICATING MODE, IS BLINKING AND THE RED HOLD/SUSPEND LED IS NO LONGER FLASHING RED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT RELEASE OUT OF HOLD MODE. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54283 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NURSE CALL CABLE PART #(B)(4), LOT #UNK