BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXIMETER

    MDR report key: 16940522 · Received May 15, 2023

    Report

    Report Number
    MW5117553
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    May 4, 2022
    Report Date
    May 10, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP- NORTHFIELD
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE HAD SEVERAL EMERGENCY ROOM VISITS SINCE 2021. MY FITBIT WATCH ACTUALLY IS MORE ACCURATE THAN THE PULSEOX METERS USED IN HOSPITALS AND DOCTORS OFFICES. I ALWAYS REQUEST AN ABG AND OFTEN DENIED. BECAUSE OF THIS I AM DENIED HOME OXYGEN THERAPY CITING MY SPO2 IS NOT AT 88%. WHICH IS UNTRUE AND THE CRITERIA FOR INSURANCE COVERED OXYGEN SHOULD BE CHANGED. IT COST MORE TO CONSTANTLY VISIT THE ER, THAN OXYGEN THERAPY AT HOME. THE IRONY IS, SOON AS I GET TO THE EMERGENCY THE FIRST THING GIVEN IS OXYGEN WHICH HELPS MY SOB. IT IS UNFAIR THAT I HAVE TO SUFFER UNNECESSARILY BECAUSE OF THE INCORRECT READING OF PULSEOX METERS. MEDICAL RECORDS ARE INCORRECTLY DOCUMENTED WITH 100% SPO2 READINGS THAT CREATE A MISDIAGNOSIS OF SYMPTOMS. (B)(6) HOSPITAL AND SEVERAL PULMONOLOGIST CONSULTS ARE CULPRITS. EX. (B)(6) 2022. I REQUESTED A ABG. FITBIT WAS READING 93, PULSE OXIMETER READ 100, ABG WAS 88. THE ABG , I WAS TOLD WAS FAULTY UNTIL DR.(B)(6) LET IT SLIP AFTER HE DENIED ME ACCESS TO THE RESULTS FOR SEVERAL DAYS. I HAVE BEEN PRESCRIBED EVERY INHALER FROM TRELEGY TO ALBUTEROL THAT ONLY HAS MADE MY SYMPTOMS WORSEN. I HAVE EVIDENCE. (B)(6) 2023. PLEASE INVESTIGATE. I CAN SUPPLY ALL MY MEDICAL RECORDS AND PICTURES OF PULSEOX METER READINGS VERSUS MY FITBIT WATCH. MY FITBIT IS MY ACCURATE AND CONGRUENT WITH THE ABG TEST. EVEN MY CARDIAC PULMONARY TEST IS INACCURATELY DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817930 PULSE OXIMETER OXIMETER DQA MEDLINE INDUSTRIES, LP- NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| S| O COREG,ENTRESTO, LASIX, METROPOLOL, TRELEGY, INCRUSE ELLIPTA, BREO ELLIPTA, ALBUTEROL, ATORVASTATIN, SPIRIVA, FARXIGA, ASPIRIN, METOLAZONE, LOSARTAN, LEXAPRO.