BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS O2-AIR MIXER 965

    MDR report key: 3150031 · Received June 3, 2013

    Report

    Report Number
    3008355164-2013-00142
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MAUDE REPORT # (B)(4) WAS RECEIVED STATING THAT: BLENDER ON TRANSPORT INCUBATOR BLED OUT TWO TANKS OF AIR DURING TRANSPORT OF BABY FROM HOSPITAL TO NICU. BABY REMAINED STABLE DURING TRANSPORT. THERE ARE NO MARKINGS ON THIS BLENDER INDICATING IT IS NORMAL FOR IT TO BLEED UP TO 10 LITERS OR THAT IT IS NOT FOR USE ON ITEMS SUCH AS TRANSPORT INCUBATORS. BLENDER CURRENTLY SEQUESTERED BY RISK MGMT AND BIOMED. IT HAS NOT BEEN TESTED OR RETURNED TO MANUFACTURER AT THIS TIME. REPORTER FEELS LABELING ON THE BLENDER IS SEVERELY LACKING. THE OUTCOME OF PATIENT WAS GOOD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242902 SIEMENS O2-AIR MIXER 965 BZR MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI