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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 Failure to Deliver; Adverse Event Without Identified Device or Use Problem
Event Date 12/24/2019
Event Type  Injury  
Event Description

The manufacturer received information alleging a oxygen concentrator was not working during a flight. The battery allegedly was depleted prior to the flight. 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 submitted 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.
312 alvin drive
new kensington PA 15068 3724
Manufacturer (Section G)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington , PA 15068
7243349303
MDR Report Key9532198
Report Number1040777-2019-00051
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1068987
Device Catalogue Number1068987
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/31/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2019
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: 12/30/2019 Patient Sequence Number: 1
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