BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 19805935 · Received July 23, 2024

    Report

    Report Number
    3004672275-2024-00050
    Event Type
    Death
    Date Received
    July 23, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 19, 2024
    Manufacturer
    INOGEN INC
    Product Code
    CAW
    UDI-DI
    00817131020513
    PMA / PMN Number
    K230052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND AN INVESTIGATION INTO THE CAUSE OF THE COMPLAINT WILL BE CONDUCTED. A FOLLOWUP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE PATIENT'S SON, THE DEVICE SEIZED UP AT APPROXIMATELY (B)(6) 2024.THE PATIENT DID NOT HAVE A BACK UP UNIT AS THE ROVE 6 WAS MARKETED TO REPLACE HER STATIONARY UNIT AND POC. HE INDICATED THAT THE SALES REP TOLD IS MOM TO GET RID OF THE HOME UNIT AND REPLACE WITH THE $5000 ROVE 6. PATIENT UTILIZED A NEBULIZER UNTIL THE AMBULANCE ARRIVED WHICH TOOK HER TO THE HOSPITAL. PATIENT WAS HOSPITALIZED AND PASSED AWAY ON (B)(6) 2024 DURING THE HOSPITALIZATION. THE PATIENT'S SON WAS UNABLE TO ELABORATE ON THE CAUSE OF DEATH FROM HOSPITAL'S PERSPECTIVE; HOWEVER, HE INDICATED THAT THE ISSUE WITH OXYGENATOR CAUSED THE DEATH OF HER MOTHER. THE PATIENT WAS ON O2 THERAPY FOR PULMONARY HTN AND AMONG OTHER LUNG ISSUES. THE UNIT WAS SET TO 2 AND HE INDICATED THAT HIS MOTHER MAY HAVE BEEN ON A HIGHER NUMBER AT THE TIME OF THE EVENT. THE UNIT WAS RETURNED TO INOGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963875 INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN INC IO-501 00817131020513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death