BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCREEN BODY

    MDR report key: 6220679 · Received January 3, 2017

    Report

    Report Number
    2021710-2017-05167
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 5, 2016
    Report Date
    January 3, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    JEH
    PMA / PMN Number
    K936108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR DETERMINED THAT THE DEVICE HAD A DEFECTIVE DEMAND VALVE AND THE COMPONENT WAS REPLACED. AFTER THE REPAIR, THE DEMAND VALVE WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. AT THIS TIME, THE CUSTOMER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE PERFORMING A LUNG DIFFUSION CARBON MONOXIDE (DLCO) TEST THE DEMAND VALVE IS CONTINUOUSLY BLOWING DURING THE PATIENT'S EFFORTS AND THE PATIENT COMPLAINED, "IT HURT HER LUNGS". THERE WAS NO FURTHER INFORMATION REGARDING PATIENT HARM OR INJURY WITH THE REPORTED ISSUE, IT IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697 MASTERSCREEN BODY PLETHYSMOGRAPH, VOLUME JEH CAREFUSION, INC MS-BODY/DIFF SES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other