BEUDAMED
    FDA Adverse Event Summary report: N

    SERVO-I

    MDR report key: 3121720 · Received May 13, 2013

    Report

    Report Number
    3008355164-2013-00115
    Date Received
    May 13, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH OXYGEN CONCENTRATION WHILE IT WAS CONNECTED TO A PT. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210520 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI