BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARM SENSOR, EZ CLEAN ALARM BELT

    MDR report key: 14579573 · Received June 2, 2022

    Report

    Report Number
    2182318-2022-00051
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Report Date
    June 16, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTS ARE SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN YET AT THE TIME OF THIS REPORT. THEREFORE; THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. 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 PREVENTIVE 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). NO PRODUCT RETURNED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    TWO SENSOR BELTS WERE RECEIVED IN FOR EVALUATION FROM THE SAME LOT NUMBER: 1153T071. ONE OF THE SENSORS WAS RECEIVED WITH CABLE APPEARED TO BE PULLED EXCESSIVELY FROM THE RJ-11 CONNECTOR AS THE INTERNAL BLACK AND RED WIRES WERE DISCONNECTED FROM THE SENSOR PIN OUTS. SCRATCH MARK OBSERVED ON THE MALE BELT BUCKLE. THE OTHER SENSOR WAS RECEIVED WITH RJ-11 CONNECTOR APPEARED TO BE DAMAGED AND OR PULLED AS TWO OF THE SENSOR PIN OUTS IN THE MIDDLE (PIN 2 AND 3) ARE COMING OUT. SCRATCHES OBSERVED ON THE SENSOR CABLE. INDENTATION MARKS ON THE FEMALE BELT BUCKLE. THE EVALUATION DID NOT CONFIRM THE REPORTED ISSUE OF NOT MAKING NOISE AS THE SENSOR BELTS CONTINUED TO TRIGGER THE IN-HOUSE 8345 UNIT TO SOUND WHEN THE BUCKLES WERE ENGAGED DUE TO DISCONNECTED WIRES AND/OR DAMAGED RJ-11 CONNECTOR. AFTER THE RJ-11 CONNECTORS WERE REPLACED WITH NEW ONES, BOTH SENSOR BELTS FUNCTIONED AS INTENDED. SOUND ISSUES MAY CAUSE FALSE ALARMS, WHICH WILL BE A NUISANCE, BUT POSE NO RISK TO THE PATIENT. ADDITIONALLY, IT IS LIKELY THAT THESE ISSUES WILL BE DISCOVERED DURING DEVICE PREP. THE VISUAL FINDINGS REVEALED SIGNS THAT THE RJ-11 APPEARED TO BE PULLED EXCESSIVELY LEAVING BOTH SENSOR BELTS TO TRIGGER THE UNIT TO SOUND WHEN IT SHOULDN'T. 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 PREVENTIVE 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 NUMBER (B)(4).

    Description of Event or Problem · 0

    CUSTOMER CALLED ABOUT TWO BELT ALARMS THAT WILL NOT MAKE NOISE. CUSTOMER STATED THESE WERE PURCHASED AT THE BEGINNING OF 2022. NO INCIDENTS OR INJURIES, NO GTIN NUMBER LOCATED. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL NEEDED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705242 ALARM SENSOR, EZ CLEAN ALARM BELT FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP TIDI PRODUCTS 8358 1153T071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown