BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPV200

    MDR report key: 19650911 · Received July 1, 2024

    Report

    Report Number
    1924066-2024-00007
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    September 16, 2022
    Report Date
    June 19, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODUCT INC
    Product Code
    BTL
    PMA / PMN Number
    K090356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS A 12 YEAR OLD UNIT THAT WAS RETURNED AND THE 5 YEAR MAINTENANCE WAS PERFORMED. IT MET ALL SPECIFICATIONS AFTER THE MAINTENANCE WAS COMPLETED.

    Description of Event or Problem · 0

    WHILE TESTING, TIDAL VOLUME LOW ON ALL SETTINGS. CUSTOMER RESPONDED: A) DATE OF DESCRIPTION 10/10/2022 - ACTUALLY HAPPENED 9/16/2022. B) DESCRIPTION OF INCIDENT: VENT WAS ALARMING HIGH AWP WHEN IT WAS ONLY READING 18-20 CMH2O WHEN I CHECKED IT THE VT WERE READING WELL BELOW SET VALUES. C) FOUND TO PRIOR TO USE? (Y/N) NO. D) FOUND DURING USE? (Y/N) YES. E) WAS A PATIENT INVOLVED? (Y/N) YES. F) IF YES, ARE THERE ANY ADVERSE EFFECTS TO THE PATIENT? (Y/N) NO. G) FOUND AFTER USE? (Y/N) NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348927 EPV200 EPV200 BTL ALLIED HEALTHCARE PRODUCT INC EPV200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown