BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 3017893 · Received March 13, 2013

    Report

    Report Number
    9611500-2013-00021
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED AFFECTED PARTS. THE INVESTIGATION IS ONGOING. WE WILL PROVIDE RESULTS IN A SEPARATE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: AT THE END OF A CASE, THE ANESTHESIOLOGIST HEARD A DISTINCT POP AND REPORTEDLY THERE WAS A FLAME AROUND THE EXPIRATORY PORT OF THE BREATHING SYSTEM. THE PT WAS DISCONNECTED AND THERE WAS NO INJURY REPORTED. A BIOMED TECH PERFORMED A PRELIMINARY INSPECTION OF THE MACHINE. WHEN HE TOOK THE BREATHING SYSTEM COVER OFF, HE NOTICED EVIDENCE OF CHARRING AND WAS THAT THE CERAMIC DISCS IN SOME OF THE VALVES ON THE VALVE PLATE WERE BROKEN IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106770 APOLLO ANESTHESIA MACHINE BSZ DRAGER MEDICAL GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1