BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1026B ANESTHETIC GAS ANALYZER

    MDR report key: 9307433 · Received November 11, 2019

    Report

    Report Number
    3007409280-2019-00089
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 17, 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 FOR EVALUATION. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND THAT THE MIRRORS HAD BROKEN OFF INSIDE OF THE DIR, THE PUMP WAS GRINDING METAL ON METAL AND SOLENOIDS #1 AND #2 OF THE PUMP HAD FAILED. DUE TO THE DAMAGE OF THE DEVICE IT WAS NOT REPAIRED; HOWEVER, IT WAS EXCHANGED. THE ROOT CAUSE FOR THE CONFIRMED REPORTED MALFUNCTION WAS DETERMINED TO BE THE DIR PUMP AND PNEUMATIC ASSEMBLY DUE TO LONG RUN HOURS AND NORMAL WEAR AND TEAR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE WAS GETTING A 02 ASSEMBLY FAILURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100697 PHILIPS M1026B ANESTHETIC GAS ANALYZER ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FGPH1026B

    Patients

    Seq Age Sex Outcome Treatment
    1