BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3941883 · Received June 3, 2014

    Report

    Report Number
    2020362-2014-00207
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 2, 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

    EVALUATION CODES: - RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND UNIT HAS NO SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD OR WHEN THE SENSOR OR MAGNET IS REMOVED FROM THE ALARM. THE RED LED LIGHT AT THE NURSE CALL TEST FIXTURE DOES NOT TURN ON WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. WARNING LABEL IS PEELED OFF. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER AND SOUNDS WHEN INITIALLY TURNED ON BUT DOES NOT SOUND WHEN IN USE WITH A SENSOR. CUSTOMER DID NOT KNOWN WHEN THE ISSUE WAS IDENTIFIED OR THE DATE WHEN THE ISSUE WAS FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323301 SITTER ELITE KMI J. T. POSEY COMPANY 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SQUARE CHAIR SENSOR PAD: MODEL :8308, LOT # UNK