BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1026B ANESTHETIC GAS MODULE

    MDR report key: 9684663 · Received February 7, 2020

    Report

    Report Number
    3007409280-2020-00040
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Report Date
    July 23, 2018
    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. DEVICE SENT IN DUE TO THE DEVICE SHUTTING DOWN IN THE MIDDLE OF A PROCEDURE. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND NO PROBLEM. THE DEVICE WAS CALIBRATED, THE CASE AND FRONT/REAR CONNECTORS WERE INSPECTED. THE CIRCUIT BOARDS WERE INSPECTED. THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED AND THERE WAS NO PROBLEM FOUND; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THIS IS BEING FILED BASED ON RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE FAILED DURING A PROCEDURE AS IT SHUT OFF. THERE WAS NO REPORT OF PATIENT HARM OR INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143217 PHILIPS M1026B ANESTHETIC GAS MODULE ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FGPH1026B

    Patients

    Seq Age Sex Outcome Treatment
    1