BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDPFT

    MDR report key: 8101289 · Received November 26, 2018

    Report

    Report Number
    8101289
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 25, 2018
    Manufacturer
    NSPIRE HEALTH INC
    Product Code
    BZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NSPIRE PFT MACHINE IN ROOM 1 HAD AN ELECTRICAL SMELL. IT WAS FOUND THAT THE GEM MODULE WAS MALFUNCTIONING. THE MANUFACTURER WAS CONTACTED BY EMAIL AND PHONE. THEY HAD THE THERAPIST TROUBLE SHOOT THE MACHINE. TECHNICAL SUPPORT FELT IT WAS DEFINITELY THE GEM AND THAT IT WOULD NEED TO BE REPLACED. TECH SUPPORT WAS SENT THE SERIAL NUMBER. NO PATIENT WAS IN THE ROOM AT THE TIME. MANUFACTURER RESPONSE FOR PFT SYSTEM, HDPFT (PER SITE REPORTER). DEVICE IS UNDER SERVICE CONTRACT. COMPANY CAME TO FACILITY AND REPLACED FAILED GEM MODULE WITH NEW MODULE AND CREATED SERVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943476 HDPFT SPIROMETER, DIAGNOSTIC BZG NSPIRE HEALTH INC HDPFT3000

    Patients

    Seq Age Sex Outcome Treatment
    1