BEUDAMED
    FDA Adverse Event Death Summary report: N

    SITTER ON CUE

    MDR report key: 15316608 · Received August 29, 2022

    Report

    Report Number
    2182318-2022-00104
    Event Type
    Death
    Date Received
    August 29, 2022
    Report Date
    August 9, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    PJO
    UDI-DI
    10190676007131
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALARM AND SENSOR WERE RECEIVED AND ANALYZED ON AUGUST 8, 2022, TIDI RECEIVED INFORMATION FROM (B)(6) HOSPITAL STATING A PATIENT DID NOT SURVIVE A FALL THAT OCCURRED IN THEIR HOSPITAL UNIT. THE HOSPITAL WAS UTILIZING 8645 POSEY ALARM AND 8309EL SENSOR PAD. THE DATE OF THE INCIDENT WAS NOT SHARED AT THAT TIME. (B)(6) HOSPITAL ASKED A TIDI TERRITORY MANAGER TO VISIT AND VERIFY THE ALARM AND SENSOR SETTINGS AND FUNCTIONALITY. ON (B)(6) 2022, A TIDI TERRITORY MANAGER AND THE TIDI DIRECTOR OF PRODUCT DEVELOPMENT VISITED THE HOSPITAL, VERIFIED SETTINGS AND PRODUCT FUNCTIONALITY AND DID NOT FIND ANY INCORRECT SETTINGS OR PRODUCT MALFUNCTIONS THAT MAY HAVE CONTRIBUTED TO THE ALARM NOT SOUNDING. THE ONLY DIFFERENCE IN SETTINGS DISCOVERED AS FOUND WAS THAT THE VOLUME WAS SET TO LOW VOLUME SETTING VERSUS THE IFU DEFAULT HIGH VOLUME SETTING. DURING THIS VISIT, TIDI PERSONNEL ALSO LEARNED THE DATE OF THE DEATH WHICH WAS ON (B)(6) 2022. THE HOSPITAL REPORTED THAT THE UNIT WAS CONNECTED TO THE NURSE CALL SYSTEM; HOWEVER, UNDER NORMAL OPERATION, THE UNIT SHOULD PROVIDE AN ALARM SIGNAL TO ALERT THEIR NURSE CALL STATION AS THE UNIT WAS SET TO LATCHING MODE. WHEN LATCHING MODE IS SELECTED AND AN ALARM SIGNAL IS INITIATED, THE NURSE CALL SIGNAL WILL CEASE ONLY WHEN THE CAREGIVER INTERACTS WITH THE ALARM. EVEN AFTER THE PATIENT RETURN TO THE SENSOR PAD, THE CAREGIVER MUST PRESS THE HOLD BUTTON TO STOP THE ALARM FROM SIGNALING THE NURSE CALL SYSTEM. TIDI PERSONNEL COLLECTED THE ALARM AND SENSOR FOR FURTHER EVALUATION. PRODUCT EVALUATION WAS CONDUCTED ON THE RETURNED UNIT AND THIS ANALYSIS CONFIRMED THE PRODUCT PASSED ALL FUNCTIONAL TESTING. DURING EVALUATION OF THE RETURNED DEVICES, THE ALARM CONDITION WAS TRIGGERED WHEN APPLIED WEIGHT WAS REMOVED FROM THE CONNECTED SENSOR. THE SYSTEM WAS HOOKED UP TO A NURSE CALL SIMULATOR AND WAS FOUND TO PROPERLY TRIGGER THE NURSE CALL SIMULATOR ALARM CONDITION WHEN APPLIED WEIGHT WAS REMOVED FROM THE CONNECTED SENSOR. DURING EVALUATION OF THE RETURNED DEVICE, THE ALARM WENT INTO MONITORING MODE, PER THE IFU, WHEN WEIGHT WAS APPLIED TO THE CONNECTED SENSOR. THE SENSOR PAD PASSED BOTH THE VISUAL AND FUNCTIONAL TESTING, AND WE WERE UNABLE TO REPLICATE THE CUSTOMER'S COMPLAINT THAT THE PRODUCT WAS NOT SOUNDING. THE NURSE CALL CABLE WAS NOT RETURNED AND EVALUATED. THE 8645 SITTER ON CUE AND 8309EL SENSOR PAD ARE ALARM AND SENSORS DESIGNED TO PROVIDE AN EARLY WARNING WHEN A PATIENT ATTEMPTS AN UNASSISTED EXIT FROM A SENSOR. THIS SYSTEM DOES NOT PREVENT FALLS OR INJURY FROM FALLS, AND IS NOT A SUBSTITUTE FOR PATIENT CARE, ROUNDING AND A COMPREHENSIVE FALLS MANAGEMENT PROTOCOL IN ANY FACILITY AS INDICATED IN THE IFU. THE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU HAS NUMEROUS WARNINGS TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH. THESE WARNINGS INCLUDE ALWAYS CHECK TO ENSURE STAFF CAN HEAR ALARM AT THE FARTHEST POSSIBLE DISTANCE BEFORE LEAVING PATIENT UNATTENDED. THE IFU CONTRAINDICATIONS INDICATE THE SITTER ON CUE MAY NOT BE SUITABLE FOR ALL HIGH FALL-RISK PATIENTS. THE SITTER ON CUE SHOULD NEVER BE USED AS THE ONLY MEANS OF SURVEILLANCE FOR: AGITATED, COMBATIVE OR SUICIDAL PATIENTS, AND PATIENTS AT EXTREME RISK OF A LIFE-THREATENING FALL. THE IFU STATES THAT TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM OR SENSOR IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR OR THE SENSOR BELT IS UNFASTENED. AT THIS TIME, TESTING OF THE PRODUCT IN QUESTION SHOWS NO EVIDENCE THAT A MANUFACTURING NONCONFORMING CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED AT THIS TIME. PER TIDI PROCEDURES, COMPLAINTS FOR THIS PRODUCT WILL CONTINUE TO BE TRENDED AND REVIEWED ON A MONTHLY BASIS. TIDI MANUFACTURER REFERENCE FILE NUMBER (B)(4).

    Description of Event or Problem · 0

    PER (B)(6) VIA EMAIL: "ON CUE ALARM AND CHAIR SENSOR - PATIENT HAD A FALL. THE PATIENT DID NOT SURVIVE THE FALL. THE DATE OF THE INCIDENT WAS NOT SHARED. THE ALARM AND SENSOR HAVE BEEN PULLED FROM THE UNIT AND IS WITH BIOMED. BIOMED HAS ASKED THAT I COME IN TO MEET WITH THEM AND LOOK AT THE ALARM AND SENSOR AND VERIFY WHAT SETTINGS IT IS ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143799 SITTER ON CUE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO TIDI PRODUCTS, LLC 8645 2105KN1965 10190676007131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death