BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR

    MDR report key: 19091038 · Received April 11, 2024

    Report

    Report Number
    3013095415-2024-00311
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 20, 2024
    Manufacturer
    INVACARE FLORIDA
    Product Code
    CAW
    PMA / PMN Number
    K200890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE HAS NOT BEEN RETURNED TO VENTEC FOR EVALUATION. THE PREVIOUS DEVICE MANUFACTURER, INVACARE, IS INVESTIGATING THE REPORTED EVENT. UPON COMPLETION OF THE PREVIOUS DEVICE MANUFACTURER'S INVESTIGATION, VENTEC SHALL BE PROVIDED WITH THE RESULTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE PREVIOUS DEVICE MANUFACTURER, INVACARE, RECEIVED A LETTER FROM STATE FARM INSURANCE ADVISING OF THE FOLLOWING EVENT: "I REPRESENT STATE FARM FIRE AND CASUALTY COMPANY REGARDING THE ABOVE LOSS INVOLVING THE HOME OF ITS INSUREDS, [REDACTED] AND [REDACTED]. ON (B)(6) 2024, THE HOME WAS DAMAGED AS THE RESULT OF A FIRE BELIEVED TO BE CAUSED BY THE FAILURE OF AN OXYGEN CONCENTRATOR MANUFACTURERED [SIC] BY INVACARE WITH A SERIAL NUMBER OF (B)(6). STATE FARM HAS EXAMINED THE HOME AND DETERMINED THAT THE ORIGIN OF THE FIRE OCCURRED AS A RESULT OF THE OXYGEN CONCENTRATOR'S FAILURE. IT IS STATE FARM'S POSITION THAT INVACARE CORPORATION'S NEGLIGENCE SURROUNDING THE OXYGEN CONCENTRATOR WAS THE CAUSE OF THE FIRE AND ITS INSURED'S DAMAGES.¿ THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE PREVIOUS DEVICE MANUFACTURER ALSO ADVISED VENTEC THAT THE UDI INFORMATION FOR THE DEVICE WAS NOT AVAILABLE, THEREFORE, SECTION D4, UDI, IS "UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651240 PERFECTO2 OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown