BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARM SENSOR, CHAIR SENSOR

    MDR report key: 19886906 · Received August 1, 2024

    Report

    Report Number
    2182318-2024-00100
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT DATABASE FOUND SIMILAR COMPLAINTS AS THE REPORTED ISSUE FOR THE LAST 2 YEARS. PRODUCTS WERE EITHER FOUND TO MEET SPECIFICATION OR PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THERE WAS NO SERIAL / LOT NUMBER PROVIDED. BEING THAT THE CUSTOMER CONFIRMED PRODUCT WORKED AS INTENDED AFTER INCIDENT. THE POSSIBLE CAUSE OF THE EVENT IS USER ERROR OR THE PATIENT MAY KNOW HOW TO PUT THE UNIT INTO HOLD MODE. 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 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 IF THE CHAIR BELT SENSOR 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

    REPORTED COMPLAINT VIA EMAIL. ITEM 8645WL + ITEM 8309WL. PATIENT FALL, THE ALARM DID NOT SOUND. PRODUCT APPEARED TO WORK AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217218 ALARM SENSOR, CHAIR SENSOR MONITOR, BED PATIENT KMI TIDI PRODUCTS LLC 8309WL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown