BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHP 300

    MDR report key: 19213344 · Received April 30, 2024

    Report

    Report Number
    1924066-2024-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    December 21, 2023
    Report Date
    April 29, 2024
    Manufacturer
    ALLIED MEDICAL LLC
    Product Code
    BTL
    UDI-DI
    00026072000014
    PMA / PMN Number
    K132021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    TIDAL VOLUMES DOES NOT MATCH SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992776 AHP 300 AHP 300 BTL ALLIED MEDICAL LLC AHP300 00026072000014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown