BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 7497527 · Received May 9, 2018

    Report

    Report Number
    9611500-2018-00128
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 4, 2018
    Report Date
    June 7, 2018
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE, AFTER REPLACING THE VENTILATOR MOTOR AND THE LIGHT BARRIER, THE DEVICE PASSED ALL SERVICE TESTS ACCORDING TO IPM-L DRÄGER SERVICE PROCEDURE. BASED ON THE EVALUATION OF THE ELECTRONIC DEVICE LOGFILE, THE REPORTED VENTILATOR FAILURE COULD BE COMPREHENDED FOR THE REPORTED DATE OF EVENT. THE LIGHT BARRIER WAS WITHOUT ANY FAILURE. FINALLY, THE MOTOR WAS DETERMINED TO BE THE ROOT CAUSE OF THE REPORTED VENTILATOR FAILURE. IN CASE THE APOLLO SHUTS DOWN AUTOMATIC VENTILATION, THE DEVICE WILL GENERATE AN AUDIBLE ALARM AND A VISIBLE ALARM MESSAGE "VENTILATOR FAIL" WILL BE DISPLAYED. IN THIS CASE AUTOMATIC VENTILATION IS NOT POSSIBLE. THE USER CAN SWITCH TO MANUAL VENTILATION AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE ELECTRICAL CONTACT BETWEEN THE COLLECTOR DISC AND THE CARBON BRUSHES WAS PARTLY DISRUPTED, DUE TO WEAR AND TEAR OF THE COLLECTOR DISC. THE KOLLMORGEN MOTOR ASM HAS BEEN DESIGNED FOR A DURABILITY OF >10 YEARS (5 HRS/DAY, 5 DAYS/WEEK, 52 WEEKS/YEAR, 13000 HOURS). IN THIS CASE WITH 17676 HOURS LOGGED, THE MOTOR HAS REACHED 136% OF THE ESTIMATED WORKING HOURS. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED DURING A CASE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342613 APOLLO ANESTHESIA UNITS CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1