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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS SIMPLY GO PORTABLE OXYGEN CONCENTRATOR
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RESPIRONICS SIMPLY GO PORTABLE OXYGEN CONCENTRATOR Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problems Hypoxia (1918); Dizziness (2194)
Event Date 06/03/2014
Event Type  Injury  
Event Description
Got the respironics simply go portable oxygen concentrator.After use i was feeling dizzy, i found my oxygen level was 79.I went to the er and got on tank oxygen.While there we looked at the product booklet and saw it said that the product may have run for twenty minutes before producing pure oxygen.I hadn't been advised of that and by the time i realized there was a problem, the unit had been on for more than an hour.After my level was at 98 for a while i attempted to get home using the portable simply go.After twelve minutes, my oxygen level was at 88.The machine appeared to be pumping and stated it was at two litres.I got a taxi and got home within five minutes, so i could get to my in home oxygen concentrator.Relevant data: i had the respironics evergo portable oxygen concentrator for a year or two before.I never had any problem with my oxygen levels while using that machine.The current vendor says most people choose to go back to tanks.I am too frail to deal with tanks and now much try to research other manufactures and don't know how to be sure to get a product that actually works.
 
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Brand Name
SIMPLY GO PORTABLE OXYGEN CONCENTRATOR
Type of Device
OXYGEN CONCENTRATOR
Manufacturer (Section D)
RESPIRONICS
MDR Report Key3870220
MDR Text Key16797254
Report NumberMW5036545
Device Sequence Number1
Product Code CAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age66 YR
Patient Weight64
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