FDA Adverse Event Injury Summary report: N

OXYGEN BLOOD SENSOR

MDR report key: 12482254 · Received September 15, 2021

Report

Report Number
MW5104036
Event Type
Injury
Date Received
September 15, 2021
Date of Event
April 5, 2021
Report Date
September 14, 2021
Product Code
PGJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS TESTED WITH BLOOD OXYGEN FINGER MACHINE AT A HOSPITAL AND IT WAS PRODUCE RESULTS SUGGESTING I WAS HEALTHY. I WAS NOT ABLE TO BREATH AND THE RESULTS CONTRADICTED IT. I WAS BELIEVED TO HAVE AN PSYCHOLOGICAL ASPECT TO MY CONDITION. IT IS NOT PSYCHOLOGICAL AND IT'S THE SECOND TIME IT'S HAPPENED. I BELIEVE THE MACHINES ARE WRONG AND WAS NOT GIVEN ANOTHER OPTION AS TO DETERMINE THE HEALTH OF MY LUNGS OR BREATHING CONDITION. I AM TRYING CALMLY TO DESCRIBE EVERYTHING REGARDLESS OF THE RISK OF TROUBLE IT MAY CAUSE AND RISK TO MYSELF SINCE IT DID NOT SUGGEST MY ACTUAL CONDITION. THE HOSPITAL DID NOT BELIEVE I WAS SICK OR HAD BREATHING PROBLEMS. (B)(6) HOSPITAL IN (B)(6) IT'S NOT THE ONLY INSTITUTION THAT HAS HAD THIS PROBLEM IT SEEMS LIKE IT'S HAPPENS WITH OTHER DEVICES. I DON'T KNOW HOW ELSE TO DESCRIBE THIS MATTER OR WHO ELSE TO TELL WHEN I AM HONESTLY SUFFERING THROUGH THIS. IT MIGHT BE WORTH DOUBLE CHECKING IN SOME FORM OF THOSE RESULTS ARE ACCURATE THEY ARE NOT ACCURATE FOR ME BUT THE MACHINES CONTRADICT MY PHYSICAL CONDITION. I DID NOT IMAGINE MY CONDITION AND AM REALLY WONDERING IF THE MACHINES ARE MISSING SOMETHING IN THE AGE OF COVID. THIS IS REALLY IMPORTANT IF THIS IS HAPPENING AND PEOPLE ARE BEING DENIED BECAUSE THE MACHINES ARE TELLING A DIFFERENT STORY WHILE THE PATIENT SUFFERS. ITS REAL AND IT'S REALLY HAPPENING I DON'T KNOW HOW ELSE TO DESCRIBE IT. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1375598 OXYGEN BLOOD SENSOR OXIMETER, WELLNESS PGJ UNSURE UNSURE

Patients

Seq Age Sex Outcome Treatment
1 30 YR Hospitalization| L| O| S