BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 4101979 · Received September 15, 2014

    Report

    Report Number
    2020362-2014-00301
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 13, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THE CONNECTOR IS NOT MISSING ON THE NURSE CALL OUTLET OF THE ALARM; HOWEVER, IT IS LOOSE. WHEN THE CUSTOMER'S NURSE CALL CABLE IS PLUGGED INTO THE RECEPTACLE AND THE CABLE IS MOVED, THE NURSES CALL LIGHT TOGGLES ON AND OFF. WHEN THE ALARM IS TESTED WITH A KNOWN WORKING NURSE CALL CABLE, THE NURSE CALL LIGHT DOES NOT COME ON. THE ALARM PASSES ALL OTHER FUNCTIONAL TESTING. THERE ARE CRACKS ON THE DUST COVERS OUTSIDE THE BATTERY COMPARTMENT. THE WARNING LABEL IS PEELED OFF. THERE ARE SCRAPES ON THE FRONT AND BACK ENCLOSURES. SEE MANUFACTURE REPORT 2020362-2014-00302 FOR NURSE CALL CABLE REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PLASTIC CONNECTOR TO THE NURSE CALL OUTLET IS MISSING AND WHEN THE NURSE CALL CABLE IS PLUGGED INTO THE RECEPTACLE, THE NURSE CALL IS SOUNDING INCONSISTENTLY AT THE NURSE'S STATION. THE CUSTOMER REPORTED THIS WAS DISCOVERED DURING USE HOWEVER THE CUSTOMER COULD NOT PROVIDE THE DATE OF THE EVENT. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569092 SITTER ELITE KMI KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NURSE CALL CABLE: MODEL 8282, LOT #N1150