BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY

    MDR report key: 19973147 · Received August 13, 2024

    Report

    Report Number
    2182318-2024-00102
    Event Type
    Injury
    Date Received
    August 13, 2024
    Report Date
    July 17, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMI
    UDI-DI
    10190676004369
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. CUSTOMER REPORTED PRODUCT HAS NOT BEEN RETURNED DUE TO AN ON GOING INVESTIGATION WITH THE EQUIPMENT. IT WAS ALSO NOTED THAT THE PATIENT SUFFERED A L3 COMPRESSION FRACTURE. BEING THAT PRODUCT HAS NOT BEEN RETURNED, A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND REVEALED SIMILAR COMPLAINTS OF 8645 ALARMS EITHER SOUNDING WHEN THEY SHOULDN¿T OR NOT SOUNDING WHEN THEY SHOULD. INVESTIGATIONS INTO THESE COMPLAINTS REVEALED THAT THE MOST LIKELY CAUSE OF THE REPORTED COMPLAINT IS EITHER DAMAGE TO THE SENSOR RECEPTACLE OR DAMAGE TO THE RJ-11 CLIP. DAMAGE CAN CAUSE THE PINS INSIDE THE SENSOR RECEPTACLE TO BECOME STUCK DOWN, EITHER TRIGGERING NO ALARM OR FALSE ALARM. IT CAN ALSO CAUSE THE SENSOR CABLE TO NOT HAVE A SECURE FIT IN THE RECEPTACLE, WHICH CAN ALLOW MOVEMENT TO AFFECT FUNCTION. LIKEWISE WITH DAMAGE TO THE SENSOR CABLE CLIP. OTHER CAUSES, SUCH AS CORROSION AND MOISTURE DAMAGE, ARE ALSO A POSSIBILITY. A DEVICE HISTORY RECORD (DHR) OF THE AFFECTED LOT NUMBER DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. NO NCRS WERE IDENTIFIED. THE PRODUCT PASSED ALL VERIFICATION TESTING AND MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. 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 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 THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. 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 (B)(4). H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    REPORTED COMPLAINT RECEIVED FROM (B)(6) HOSPITAL. WE JUST HAD A FALL WITH A SERIOUS INJURY, APPEARS A CHAIR ALARM DID NOT GO OFF, BEING INSPECTED BY BIO MED, BUT CANNOT FIND ANYTHING WRONG, RISK IS GIVING UP NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200986 ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY MONITOR, BED PATIENT KMI TIDI PRODUCTS LLC 8309EL 4136T129 10190676004369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown