BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1026B ANESTHETIC GAS ANALYZER

    MDR report key: 9399544 · Received December 2, 2019

    Report

    Report Number
    3007409280-2019-00120
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 5, 2019
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    CBQ
    PMA / PMN Number
    K040917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE TOP CASE DAMAGED AND THE BOTTOM CASE LOCKING CAM WAS BROKEN. THE ERROR LOG SHOWED SOLENOID 1 AND 2 FAILURE, AND THE LAMP WAS ONLY READING CO2 UP TO 4.7. THE UNIT WAS RAN FOR 28 HOURS CONFIRMING THE INTERMITTENT CONNECTION AND FAILURE TO ZERO OUT. THE PUMP OUTLET FILTER, LAMP, LOCKING CAM, TOP CASE, AND RS232 CABLE WERE ALL REPLACED. THE UNIT WAS TESTED FOR 24 HOURS SHOWING THAT THE SOLENOID ISSUE 1 AND 2, CONNECTION, AND ZERO ISSUES RESOLVED. THE ROOT CAUSE WAS DETERMINED TO BE THE MICRON FILTER AND RS232 CABLE. AS THE PUMP IS RAN SHAVINGS FROM PUMP ARE CAUGHT PURPOSELY BY MICRON FILTER CAUSING IT TO FILL UP OVER TIME. THE RS232 CABLE SHOWED NORMAL WEAR AND TEAR DUE TO LONG RUN HOURS. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE WOULD NOT ZERO AND DISPLAYED 02 ASSEMBLY FAILURE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193426 PHILIPS M1026B ANESTHETIC GAS ANALYZER ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FGPH1026B

    Patients

    Seq Age Sex Outcome Treatment
    1