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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 1113605
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 03/29/2020
Event Type  Death  
Event Description

The manufacturer received information alleging an oxygen concentrator was not functioning properly. The patient's blood oxygen level was low. The patient expired at a later date. It is unknown if the patient was using the device at the time of death. The investigation is still ongoing for this issue. 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.
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 Key9920587
Report Number2518422-2020-00825
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1113605
Device Catalogue Number1113605
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/10/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2019
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: 04/03/2020 Patient Sequence Number: 1
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