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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. SIMPLYGO MINI OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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PHILIPS RESPIRONICS INC. SIMPLYGO MINI OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1113601
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/18/2019
Event Type  Death  
Event Description

The manufacturer received information alleging a patient expired after using an oxygen concentrator. The investigation is still ongoing. A follow up report will be submitted when the manufacturer has completed the investigation.

 
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Brand NameSIMPLYGO MINI OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068 3724
Manufacturer (Section G)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key9117832
MDR Text Key160007578
Report Number1040777-2019-00045
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2019
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1113601
Device Catalogue Number1113601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/04/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/25/2019 Patient Sequence Number: 1
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