BEUDAMED
    FDA Adverse Event Other Summary report: N

    APOLLO

    MDR report key: 2210074 · Received July 29, 2011

    Report

    Report Number
    9611500-2011-00024
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    April 30, 2011
    Report Date
    July 28, 2011
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS INTUBATING A PT AND WAS NOT GETTING CO2 READINGS ALTHOUGH THE TUBE APPEARED TO BE PROPERLY INSERTED. THE DOCTOR REPORTEDLY EXTUBATED THE PT AND TRIED INTUBATING AGAIN BUT STILL WASN'T SEEING ANY CO2 READINGS SO HE REPORTEDLY WAS NOT SURE THE TUBE WAS PROPERLY INSERTED. IT WAS REPORTED THAT THE DOCTOR DECIDED TO DO A TRACHEOTOMY IN ORDER TO VENTILATE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOLLO ANESTHESIA MACHINE BSZ DRAGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other