BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY

    MDR report key: 20087237 · Received August 28, 2024

    Report

    Report Number
    2182318-2024-00111
    Event Type
    Injury
    Date Received
    August 28, 2024
    Report Date
    June 13, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMI
    UDI-DI
    10190676007131
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 THE DEVICE WAS RETURNED AND EVALUATED BY TIDI PRODUCTS; AT WHICH TIME IT WAS FOUND TO BE FUNCTIONING ACCORDING TO MANUFACTURING SPECIFICATIONS. PRODUCT PASSED ALL FUNCTIONAL TESTING, THEREFORE, THE EVIDENCE SUPPORTS THAT A DEVICE MALFUNCTION DID NOT OCCUR. 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).

    Description of Event or Problem · 0

    ADDITIONAL PRODUCT PART 8309EL WAS RETURNED FOR EVALUATION. CUSTOMER REPORTING A COMPLAINT ON PRODUCT PART 8645. CUSTOMER STATES THAT THEY HAD A PATIENT FALL. PATIENT WAS FOUND ON THE FLOOR AFTER THE STAFF HEARD A THUMP IN THE PATIENT'S ROOM. THE ALARM WAS TESTED AND IT WORKED JUST FINE. THE HUSBAND MAY HAVE UNPLUGGED THE CORD SINCE HE HAD IT UNPLUGGED EARLIER. THERE WAS A WRIST FRACTURE AS A RESULT OF FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179834 ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY MONITOR, BED PATIENT KMI TIDI PRODUCTS LLC 8309EL 4113T031 10190676007131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown