BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 428 SW,440 ML W/028 ADAPTOR,FRE

    MDR report key: 12124598 · Received July 6, 2021

    Report

    Report Number
    1417411-2021-00012
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 14, 2021
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE CONNECTION BETWEEN THE NEBULIZER TO THE GAZ IS UNSECURED. THE SCREW ADAPTOR IS TOO FRAGILE". UNKNOWN IF PATIENT WAS INVOLVED AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019154 HUDSON AQUAPAK 428 SW,440 ML W/028 ADAPTOR,FRE HUMIDIFIER NEBULIZER KIT OGG 74K1900597

    Patients

    Seq Age Sex Outcome Treatment
    1