BEUDAMED
    FDA Adverse Event Other Summary report: N

    APOLLO

    MDR report key: 1810652 · Received July 28, 2010

    Report

    Report Number
    9611500-2010-00030
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    May 20, 2010
    Report Date
    July 28, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS FILED IN RESPONSE TO (B)(4). THE MENTIONED USER FACILITY REPORT DESCRIBES A PROBLEM RELATED TO A SYSTEM CONSISTING OF AN ANESTHESIA MACHINE APOLLO, THE PATIENT CHARTING PROGRAM COMPURECORD AND THE DIGITAL ACQUISITION UNIT BAYTECH. IT IS TO REVEAL THAT THIS SYSTEM WAS NOT TESTED, APPROVED OR ADVERTISED BY DRAEGER. THEREFORE DRAEGER IS NOT THE MANUFACTURER OF THIS SYSTEM. DRAEGER AFFIRMED THAT ALL SOURCE CODES FOR THEIR MEDIBUS PROTOCOL OF THE APOLLO IS PROVIDED TO VENDORS. THERE ARE TWO SOFTWARE VERSIONS CURRENT IN APOLLO MACHINES; VERSION 3.21 AND VERSION 4.10. THE REPORTED COMMUNICATION PROBLEMS AND RESULTING GAPS IN THE DEVICE DATA ARE NOT CAUSED BY A DEVIATION IN THE SOFTWARE OF THE APOLLO. ADDITIONALLY THE SPECIFIC MEDIBUS PROTOCOL SPECIFICATIONS OF APOLLO CAN BE OBTAINED BY DRAEGER MEDICAL UPON REQUEST. THE REPORTED "COM PORT 1 FAILURE" CAN CAUSE A GAP IN THE PATIENT'S DATA RECORD BUT THE BASIC DEVICE FUNCTIONS OF THE APOLLO "INTEGRATED MONITORING" AND "ALARM SYSTEMS" ARE NOT AFFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UPGRADE OF THE HOSPITAL'S COMPURECORD PATIENT CHARTING PROGRAM FROM VERSION D.02 TO F.00 WAS NECESSARY TO ALLOW OPERATION WITH BAYTECH'S NEW MODEL DS3 ACQUISITION UNIT (UPGRADE WAS NECESSARY BECAUSE THE HOSPITAL'S EXISTING BAYTECH M4 AND M8 MODELS ARE NO LONGER AVAILABLE). IT WAS REPORTED THAT AFTER THE UPGRADE WAS COMPLETED, USERS REPORTED THAT A "COMM PORT 1 FAIL" ERROR MESSAGE WAS OCCURRING PERIODICALLY ON THEIR APOLLO ANESTHESIA MACHINES. IT WAS DETERMINED THAT ON APOLLO ANESTHESIA MACHINES USING THE BAYTECH M4 OR M8 MODELS, THE "COMM PORT 1 FAIL" MESSAGE WAS DISPLAYED BRIEFLY AT TEN SECOND INTERVALS, ALTHOUGH THE ACTUAL PATIENT DATA ACQUISITION AND RECORDING SEEMED UNAFFECTED. FOR APOLLO MACHINES USING THE DS3 ACQUISITION UNIT, THERE WAS REPORTEDLY NO ERROR MESSAGE DISPLAYED, BUT THE ACQUIRED PATIENT DATA IN THE COMPURECORD CHART WOULD APPEAR FOR 15 SECONDS AND DISAPPEAR FOR 30 SECONDS, PRODUCING PERIODIC GAPS IN THE PATIENT'S SAVED DATA RECORD. THERE HAVE BEEN NO PATIENT INJURIES REPORTED ASSOCIATED WITH THIS BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOLLO ANESTHESIA UNIT BSZ DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA