BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 2233358 · Received August 31, 2011

    Report

    Report Number
    2233358
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DRAEGER GMBH
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DRAEGER APOLLO ANESTHESIA MACHINE HAS THE PT. MONITOR MOUNTED TO AN ARM THAT IS ATTACHED TO THE MAIN BODY OF THE ANESTHESIA-GAS MACHINE BY SCREWS ATTACHED TO A TWO AND SEVEN-EIGHTH INCH SQUARE ALUMINUM PIECE IN A TRACK HELD IN BY M6 SCREWS. BOTH ALUMINUM PIECES FAILED BECAUSE OF THREAD FAILURE. THE ALUMINUM THREADS WERE STILL ATTACHED TO THE SCREWS WHEN THEY WERE RECOVERED FROM THE FLOOR. THIS IS THE SECOND OCCURENCE OF THIS PROBLEM.====================== MANUFACTURER RESPONSE FOR ANESTHESIA MACHINE/MONITOR, APOLLO (PER SITE REPORTER)======================THEY WERE CONTACTED FOR THE FIRST EVENT. THEY COULD NOT LOCATE A PART NUMBER OR THE CORRECT PART FOR THE FAILED ALUMINUM PIECE. I WILL CALL THEIR QUALITY CONTROL DEPARTMENT ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOLLO GAS-MACHINE, ANESTHESIA BSZ DRAEGER GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *