BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ON CUE

    MDR report key: 14605498 · Received June 6, 2022

    Report

    Report Number
    2182318-2022-00053
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Report Date
    May 9, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CODES: TESTING OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE OF THE ALARM NOT SENDING A SIGNAL TO THE NURSE CALL STATION DUE TO A FAULTY Q1 (TRANSISTOR). ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. HOWEVER, DUE TO THE PRODUCT BEING OVER A YEAR OLD, IT'S POSSIBLE WEAR AND TEAR CONTRIBUTED TO THE FAILURE. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE PASSED ALL PRODUCT VERIFICATION TESTING AND MET SPECIFICATIONS PRIOR TO BEING SHIPPED. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES "WHEN USING A NURSE CALL CABLE, ENSURE THE NURSE CALL CABLE IS PLUGGED IN TO BOTH THE ALARM AND THE WALL JACK BEFORE LEAVING THE PATIENT UNATTENDED. VERIFY THAT AN ALERT IS RECEIVED AT THE NURSING STATION IF THE CABLE IS UNPLUGGED FROM THE WALL JACK. NOTE: THERE WILL BE NO ALERT AT THE NURSING STATION OR AT THE BEDSIDE IF THE NURSE CALL CABLE IS UNPLUGGED FROM THE ALARM." THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THE NURSE CALL CABLE IS NOT WORKING. WILL SEND IN FOR INSPECTION. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158762 SITTER ON CUE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO TIDI PRODUCTS 8645 2105KN1554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown