BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS ANESTHESIA GAS MONITOR

    MDR report key: 9106792 · Received September 23, 2019

    Report

    Report Number
    3007409280-2019-00020
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 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 IDENTIFIED CASE DAMAGE AND THAT THERE WAS NO WATER TRAP. TECHNICAL VISUAL INSPECTION IDENTIFIED NO ANOMALIES. DEVICE EVALUATION FOUND THAT THE PUMP WAS VERY WEAK. THIS WAS NOT RELATED TO THE PREVIOUS REPAIR AS THIS IS PART WAS NOT REPAIRED AT THAT TIME. THE PUMP WAS REPLACED AND THE DEVICE TESTED TO OEM SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THE DEVICE TURNING OFF COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT IT WAS RELATED TO THE BAD PUMP. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE TURNS OFF DURING USE. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901887 PHILIPS ANESTHESIA GAS MONITOR ANESTHETIC GAS MODULE CBQ PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH M1026B

    Patients

    Seq Age Sex Outcome Treatment
    1