BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS3000

    MDR report key: 2981020 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00026
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 22, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    080175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE BREATHING SYSTEM AND PEEP VALVE. THE SYSTEM WAS TESTED TO FACTORY'S SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AS3000 WOULD INTERMITTENTLY SHUT DOWN DURING VENTILATION MODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38581 AS3000 NONE MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1