BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1026B ANESTHETIC GAS MODULE

    MDR report key: 9212555 · Received October 20, 2019

    Report

    Report Number
    3007409280-2019-00046
    Event Type
    Malfunction
    Date Received
    October 20, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 27, 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 DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION CORNER DAMAGE ON THE TOP CASE. DEVICE EVALUATION FOUND THAT THE O2 MODULE HAD A COMMUNICATION ERROR AND THE O2 READING WAS TOO HIGH. ADDITIONALLY, THE PUMP WAS FAILING THE CALIBRATION FLOW CHECK. THE PUMP WAS REPLACED. THE O2 MODULE WAS REPLACED, AND THE O2 COMMUNICATING AND READING WAS SET AT THE CORRECT LEVEL. THE DEVICE WAS CALIBRATED AND THE TESTED TO OEM SPECIFICATION. THE FAN, FAN FILTER, FLOW RATE, GAS CALIBRATION AND SPAN TEST, LEAK CHECK, POWER ON TEST, AND PRESSURE SENSOR WERE ALL CHECKED ALL PASSED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE PUMP WAS AGED MOST LIKELY FROM LONG RUN HOURS. THIS WAS RELATED TO THE PREVIOUS REPAIR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE O2 ANALYZING CHANNEL FAILED. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006311 PHILIPS M1026B ANESTHETIC GAS MODULE ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FGPH1026B

    Patients

    Seq Age Sex Outcome Treatment
    1