BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUGBOX PLUS

    MDR report key: 5633712 · Received May 2, 2016

    Report

    Report Number
    MW5062091
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Date of Event
    March 24, 2016
    Report Date
    May 2, 2016
    Manufacturer
    KINN TECHNOLOGY LTS.
    Product Code
    JTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LAB STAFF NOTED AIR OR GAS FREQUENTLY COMPRESSING INTO CHAMBER AND CONCERNED ABOUT HYDROGEN LEAK. MEDICAL GAS CYLINDER CHANGED AND CHECKED FOR GAS LEAK AND FOUND NONE. ON FURTHER INSPECTION OF BUGBOX, STAFF FOUND A WHITE TUBING ON LEFT SIDE IN CHAMBER DISCONNECTED. TUBE RECONNECTED. TUBE DOES NOT HAVE CLAMP OR OTHER METHOD OF SECURING CONNECTIVITY. TECHNICAL REPRESENTATIVE (B)(6) FROM BUGBOX CONTACTED FOR SUPPORT AND TROUBLE SHOOTING. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279512 BUGBOX PLUS ANAEROBIC B OX JTM KINN TECHNOLOGY LTS.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other