BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1026B ANESTHETIC GAS ANALYZER

    MDR report key: 9406819 · Received December 3, 2019

    Report

    Report Number
    3007409280-2019-00121
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 8, 2019
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    CBQ
    PMA / PMN Number
    K040917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE DEVICE CAME IN WITH THE MICRON FILTER DISCONNECTED AND THE PUMP WAS BAD. THE PUMP WAS REPLACED. THE FAN, FAN FILTER, FLOW RATE, GAS CALIBRATION, LEAK, POWER ON, PRESSURE SENSOR, AND FINAL VISUAL INSPECTION WERE CHECKED/TESTED AND ALL PASSED. THE ROOT CAUSE WAS DETERMINED TO BE THE DEFECTIVE PUMP. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE'S O2 ZERO FAILED AND AGM ZERO FAILED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199456 PHILIPS M1026B ANESTHETIC GAS ANALYZER ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FGPH1026B

    Patients

    Seq Age Sex Outcome Treatment
    1