BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 17498233 · Received August 9, 2023

    Report

    Report Number
    MW5122860
    Event Type
    Other
    Date Received
    August 9, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 6, 2023
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN (B)(6) 2023 MY PULMONARY DOCTOR PRESCRIBED SUPPLEMENTAL OXYGEN 24/7. THE INOGEN G5 PORTABLE OXYGEN WAS THE ONE THAT WAS PRESCRIBED. FROM (B)(6) 2023, I'VE HAD FIVE DIFFERENT INOGEN G5'S ALL WERE DEFECTIVE AND FAILED WITH ERRORS INDICATING THEY WERE NOT SUPPLYING THE PROPER OXYGEN. THE LAST TWO UNITS AFTER LESS THAN 36 HOURS OF SERVICE. INOGEN CUSTOMER SERVICE WAS CONTACTED AFTER EVERY FAILURE AND THEIR SOLUTION WAS TO SEND ANOTHER DEFECTIVE UNIT. INOGEN OBVIOUSLY HAS A SERIOUS DEFECT AND QUALITY PROBLEM WITH THEIR PRODUCT. DEPENDING WHEN THE UNIT FAILS, IT CAN TAKE UP TO 5 DAYS TO GET A REPLACEMENT. A COMPLAINT WAS FILED WITH THE BBB ABOUT INOGEN'S DEFECTIVE PRODUCT. WE DID NOT REACH AN AGREEABLE SOLUTION. IN FACT, INOGEN RESPONSE CONTAINED TWO FALSE STATEMENTS. REFERENCE REPORTS MW5122856, MW5122857, MW5122858, MW5122859.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784289 INOGEN G5 PORTABLE OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW INOGEN, INC. INOGEN ONE G5

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Disability AMLODIPINE BESYLATE | ASPIRIN | CRESTOR | EPERENONE | FLONASE| LOSARTAN | METOPROLOL | MUCINEX | NEBULIZER - IPRATROPIUM & ALBUTEROL| NEXIUM | PLAVIX | PROAIR | RANOLAZINE | SUPPLEMENTAL OXYGEN| TRELEGY | XANAX