BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR CIRCUIT,PEDIATRIC W/WATER TR

    MDR report key: 11747700 · Received April 29, 2021

    Report

    Report Number
    3004365956-2021-00167
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    February 15, 2021
    Report Date
    April 14, 2021
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION OF THE PRODUCT INVOLVED WAS PERFORMED ON A PICTURE PROVIDED BY THE CUSTOMER. IT CAN OBSERVE THE PART NUMBER 10714-01 (4 NYLON TIE STRAP) LOOSE FROM 22 MM ADAPTOR. HOWEVER, THE PICTURE IS NOT CLEAR ENOUGH TO DETERMINE ALLEGED ISSUE "LEAK-OTHER". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED "PRIOR TO USE, THEY TESTED THE CIRCUIT AND FOUND OUT AN AIR ESCAPE LOCATED IN THE BAND THAT IS ATTACHED TO THE FILTER, IT LOOKS BROKEN". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641217 HUDSON VENTILATOR CIRCUIT,PEDIATRIC W/WATER TR CIRCUIT, BREATHING (W CONNECTO CAI 74F1900018

    Patients

    Seq Age Sex Outcome Treatment
    1