BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE® HOMEFILL® OXYGEN SYSTEM

    MDR report key: 21893194 · Received April 23, 2025

    Report

    Report Number
    3013095415-2025-00366
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    August 1, 2024
    Report Date
    April 23, 2025
    Manufacturer
    INVACARE FLORIDA
    Product Code
    CAW
    PMA / PMN Number
    K003939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE PATIENT CONTACTED VENTEC DIRECTLY, AS A RESULT, SECTION E1 NAME AND ADDRESS ARE NA, AND THE PHONE NUMBER SHALL BE LEFT BLANK, TO PROTECT THEIR PRIVACY. THIS DEVICE WAS MANUFACTURED AND PLACED INTO COMMERCIAL DISTRIBUTION BACK IN JULY OF 2004, WHICH PREDATES THE REQUIRED UDI COMPLIANCE DATE FOR CLASS II MEDICAL DEVICES. AS A RESULT, NO UDI# EXISTS FOR THIS DEVICE AND SECTION D4, UDI#, STATE NONE. VENTEC CONTINUES TO INVESTIGATE THE REPORTED ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 -- SECTION D3, MFG ESTABLISHMENT NAME, OF THE INITIAL MEDWATCH REPORT STATED: VENTEC LIFE SYSTEMS, INC. SECTION D3, MFG ESTABLISHMENT NAME, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: INVACARE (B)(6). SECTION D3, ADDRESS 1, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION D3, ADDRESS 1, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION D3, CITY, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION D3, CITY, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION D3, ZIP CODE, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION D3, ZIP CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT AN INVACARE® HOMEFILL® OXYGEN SYSTEM WOULD NOT FILL. THE REPORTER, A PATIENT, ADVISED THAT THE TOP TANK HAD BEEN ON FOR 24 HOURS AND WOULD NOT FILL. THE PATIENT FURTHER ADVISED THAT IT ALSO MAKES A LOUD NOISE AND VIBRATES DURING OPERATION, AND THAT SHE HAD EXPERIENCED THESE ISSUES SINCE LAST AUGUST (2024) DESPITE A TECHNICIAN VISITING MULTIPLE TIMES TO EXAMINE/REPAIR IT. THE PATIENT STATED THAT SHE HAD TO GO TO THE HOSPITAL DUE TO THE ISSUES SHE¿S EXPERIENCED WITH THE DEVICE, HOWEVER, NO DETAILS ABOUT HER HOSPITAL VISIT OR CONDITION WERE PROVIDED. IT IS ALSO UNCLEAR WHAT THE ISSUE WAS WITH THE DEVICE WHICH MAY HAVE CAUSED THE PATIENT TO BE HOSPITALIZED, AS WHAT WAS REPORTED IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621199 INVACARE® HOMEFILL® OXYGEN SYSTEM GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA IOH200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization