FDA Adverse Event Injury Summary report: N

GCE ZEN-O LITE PORTABLE OXYGEN CONCENTRATOR

MDR report key: 10319869 · Received July 23, 2020

Report

Report Number
MW5095697
Event Type
Injury
Date Received
July 23, 2020
Report Date
July 22, 2020
Manufacturer
GCE GAS CONTROL EQUIPMENT INC.
Product Code
CAW
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT HAS A PORTABLE OXYGEN CONCENTRATOR (POC) WITH A PULSE SETTING (LIKE SEVERAL POCS DO) AND HAS IT SET ON "3" THINKING THAT IT CORRELATES WITH THEIR PRESCRIPTION OF 3LPM. IT DOES NOT. PT WAS FOUND SEVERELY HYPOXIC (SPO2 67%) WHEN CHECKED. THIS IS A COMMON MISCONCEPTION FROM NOT ONLY THIS PT, BUT THE VAST MAJORITY OF MY PTS, WHO ARE ON POC. THEY ARE NEVER INSTRUCTED OF THE DIFFERENCE. THERE IS NOTHING ON THE LABELING DENOTING A DIFFERENCE IN DELIVERED O2 RATES/VOLUMES. PTS ARE EXCITED TO RECEIVE A DEVICE THAT IS LIGHTER THAN A TYPICAL E CYLINDER AND TO HAVE MORE FREEDOM, BUT ARE NOT EDUCATED AND AREN'T GOING TO READ A MULTIPAGE ONLINE MANUAL WHEN "2 SHOULD BE 2, NOT 35ML". THIS PT REQUIRED US TO GRAB AN E CYLINDER TO RECOVER AND SPEND TIME EDUCATING HIM AND CALLING HIS DME TO HAVE TANKS AVAILABLE FOR EXERCISE (WHICH HE WAS PRESCRIBED 2-3LPM BASELINE AND 3-4 FOR ACTIVITY). EVEN CLINICAL PROVIDERS DO NOT KNOW THAT "2 ISN'T 2". THERE NEEDS TO BE BETTER/CLEAR LABELING WITH THE LIMITATIONS OF PULSE SETTINGS CLEAR. EX: IT IS RECOMMENDED FOR PTS ON 2LPM OR LESS CONTINUOUSLY AND, MAYBE, A PULSE SETTING CHART WITH VOLUME DELIVERED AT X RESPIRATORY RATE. THE PT POPULATION WITH PORTABLE O2 TENDS TO BE AN OLDER GROUP, SO IT SHOULD BE EASILY SEEN. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
782218 GCE ZEN-O LITE PORTABLE OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW GCE GAS CONTROL EQUIPMENT INC.

Patients

Seq Age Sex Outcome Treatment
1 67 YR Required Intervention