BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERX

    MDR report key: 20756956 · Received November 22, 2024

    Report

    Report Number
    3009096682-2024-00102
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    February 22, 2023
    Report Date
    November 22, 2024
    Manufacturer
    MME WILLOW LAKE
    Product Code
    CAW
    PMA / PMN Number
    K200496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER THAT A PORTABLE OXYGEN CONCENTRATOR "BURNED UP". NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600989 AERX GENERATOR, OXYGEN, PORTABLE CAW MME WILLOW LAKE AX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown