BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHAPORT

    MDR report key: 9205647 · Received October 17, 2019

    Report

    Report Number
    9710055-2019-00308
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 5, 2019
    Manufacturer
    MAQUET SAS
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS ESTABLISHED THAT THE DEVICE WHICH WAS INVOLVED IN THIS ISSUE IS NOT UNDER MAQUET SAS RESPONSIBILITY, BUT UNDER MAQUET (SUZHOU) CO.,LTD. RESPONSIBILITY. THEREFORE, THE CASE WILL BE FURTHER EVALUATED UNDER MANUFACTURER REPORT NUMBER 3007417753-2019-00002.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6), 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ALPHAPORT DEVICE. AS IT WAS STATED, THE COVER OF FLUID DELIVERY ARM FELL INTO OPERATING FIELD. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT CAUSE A CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997407 ALPHAPORT TUBING, PRESSURE AND ACCESSORIES BYX MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1