BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 4993205 · Received July 31, 2015

    Report

    Report Number
    9611500-2015-00152
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 31, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INVESTIGATED ON SITE BY A SERVICE TECHNICIAN OF THE HOSPITALS CONTRACTED SERVICE ORGANIZATION AND THE DEVICE LOG WAS DOWNLOADED AND FORWARDED TO THE MANUFACTURER. THE DEVICE PASSED ALL TESTS ON SITE AND PERFORMED AS EXPECTED. THE DEVICE LOG CONFIRMS THAT THE DEVICE SWITCHED TO MANUAL VENTILATION MODE WITH CORRESPONDING ALARM ON THE DATE OF OCCURRENCE. MONITORING FUNCTIONS WERE STILL AVAILABLE. THE INVESTIGATION COMES TO THE CONCLUSION THAT THE REPORTED EVENT WAS A SPORADIC INTERNAL COMMUNICATION PROBLEM OF THE VENTILATOR'S CPU BOARD WHICH WAS MOST LIKELY CAUSED BY ELECTROMAGNETIC RADIATION OR ELECTROSTATIC DISCHARGE OF THE USER DURING INTERACTIONS WITH THE DEVICE. DRAGER HAS RECOMMENDED IN THE INVESTIGATION REPORT TO REPLACE THE CPU BOARD AS PRECAUTIONARY MEASURE AND TO CHECK ELECTROMAGNETIC ENVIRONMENT IN THE CONCERNED ROOM IN THE HOSPITAL. THE NUMBER OF SIMILAR EVENTS IS VERY RARE COMPARED TO THE INSTALLED BASE OF THIS TYPE OF DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE MACHINE ALARMED FOR 'GAS DELIVERY + VENT FAIL' AND STOPPED AUTOMATIC VENTILATION. THE CASE WAS COMPLETED IN MANUAL MODE AND THERE WAS NO PATIENT INJURY REPORTED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502262 APOLLO ANESTHESIA MACHINE BSZ DRAEGER MEDICAL GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1