BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHP300

    MDR report key: 19651253 · Received July 1, 2024

    Report

    Report Number
    1924066-2024-00014
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    December 21, 2022
    Report Date
    June 26, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODUCT INC.
    Product Code
    BTL
    PMA / PMN Number
    K132021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR REPAIR AND WAS RECALIBRATED AND TESTED. IT MET ALL SPECIFICATIONS AFTER THE CALIBRATION WAS COMPLETED.

    Description of Event or Problem · 0

    LOW TIDAL VOLUME AND SYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565665 AHP300 AHP300 BTL ALLIED HEALTHCARE PRODUCT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown