BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ON CUE PRO

    MDR report key: 14115820 · Received April 14, 2022

    Report

    Report Number
    2182318-2022-00030
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Report Date
    March 18, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. CUSTOMER RESPONDED THE DUE DILIGENCE EMAIL STATING THAT THE PATIENT DID NOT SUSTAIN INJURY AND ACKNOWLEDGED THAT THE EQUIPMENT WAS NOT PROPERLY PAIRED WHICH KEPT THE DEVICE FROM MONITORING THE PATIENT. THE TERRITORY MANAGER (TM) WHO IS ASSIGNED TO THIS CUSTOMER STATED THAT NEITHER THE ALARM NOR THE CORRESPONDING ACCESSORIES WERE AT FAULT. IT WAS A USER ERROR. THE TM CONDUCTED RETRAINING WITH THE ENTIRE TEAM FOR MITIGATING THE ISSUE FROM REOCCURRING. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES, TEST FALL MONITOR FUNCTIONALITY EVERY TIME BEFORE EACH USE AND WHEN LEAVING THE PATIENT UNATTENDED. ENSURE THE NURSE CALL CABLE IS PLUGGED INTO BOTH THE FALL MONITOR AND THE WALL PORT OF THE NURSE CALL SYSTEM OR THAT THE WIRELESS ADAPTER IS PAIRED PROPERLY BEFORE LEAVING THE PATIENT UNATTENDED. VERIFY THAT AN ALERT IS RECEIVED AT THE NURSING STATION. MOREOVER, THE WIRELESS ALARM SETUP GUIDE ALSO STATES, TURNING OFF THE ALARM UNPAIRS THE WIRELESS CHAIR SENSOR PAD. NEVER TURN OFF THE WIRELESS NURSE CALL ADAPTER OR IT WILL UNPAIR FROM THE ALARM. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. 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. MANUFACTURE REFERENCE FILE # (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THERE WAS A FALL THAT TOOK PLACE WITH THE SITTER ON CUE PRO ALARM. THE PATIENT FALL INVOLVED A PT TEAM MEMBER WHO MAY HAVE ACCIDENTALLY UNPAIRED THE ALARM AND SENSOR BY TURNING OFF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042932 SITTER ON CUE PRO FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO TIDI PRODUCTS 8645WL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown