BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3915156 · Received May 15, 2014

    Report

    Report Number
    2020362-2014-00189
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    March 3, 2014
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED ALARM FOUND THE NURSE CAL LED LIGHT DOES NOT TURN ON WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD DUE TO A FAULTY NURSE CALL RECEPTACLE. THE NURSE CALL RECEPTACLE IS BROKEN AND THERE ARE SCUFF MARKS ON THE NURSE CALL RECEPTACLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS UNABLE TO PROVIDE ANY INFORMATION OTHER THAN THE ALARM IS NOT WORKING. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289578 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK