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U.S. Department of Health and Human Services

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

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PHILIPS RESPIRONICS INC. SIMPLYGO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1068987
Device Problems Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown
Event Date 04/24/2020
Event Type  Injury  
Event Description

The manufacturer received information alleging an oxygen concentrator shut down intermittently. The patient was admitted to the hospital. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed when the manufacturer has completed the investigation.

 
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Brand NameSIMPLYGO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
1001 murry ridge lane
murrysville, pa
Manufacturer (Section G)
PHILIPS RESPIRONICS INC.
1001 murry ridge lane
murrysville, pa
Manufacturer Contact
adam price
1001 murry ridge lane
murrysville, pa  
MDR Report Key10009114
Report Number2518422-2020-01084
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1068987
Device Catalogue Number1068987
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/07/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2020
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: 04/29/2020 Patient Sequence Number: 1
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