BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY

    MDR report key: 20138350 · Received September 4, 2024

    Report

    Report Number
    2182318-2024-00114
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Report Date
    September 11, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMI
    UDI-DI
    10190676004352
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6 VISUAL FINDINGS OBSERVED PRODUCT CAME FOLDED IN A BOX. THE DATE OF FIRST USE WAS NOT IDENTIFIED. EVALUATION FOUND THE PRODUCT HAD NO DEAD SPOTS, AND NEVER FAILED ONCE TO ACTIVATE THE ALARM ONCE THE PRESSURE WAS RELIEVED FROM THE SENSOR PAD. PRODUCT PASSED ALL FUNCTIONAL TESTING AND PERFORMED AS INTENDED. 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).

    Additional Manufacturer Narrative · 0

    H3: THE PRODUCT IS SCHEDULED TO BE RETURNED BUT HAS NOT BEEN RECEIVED IN BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. 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. NEVER JERK OR PULL ON THE CORD TO REMOVE THE SENSOR CORD PLUG. DOING SO WILL DAMAGE CORD WIRES OF FALL MONITOR. 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). PRODUCT NOT YET RETURNED.

    Description of Event or Problem · 0

    SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    COMPLAINT REPORTED THE PATIENT FELL BECAUSE OF THE SENSOR PAD NOT ACTIVATING THE ALARM. THEY ARE USING THE SITTER ON CUE PRO ALARM AND TESTED ANOTHER PAD AND IT WORKED AS DESIGNED. I DO NOT KNOW IF THE PATIENT SUSTAINED AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899118 ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY MONITOR, BED PATIENT KMI TIDI PRODUCTS LLC 8309 4127T002 10190676004352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown