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U.S. Department of Health and Human Services

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

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PHILIPS RESPIRONICS INC. SIMPLYGO MINI GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1113601
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/30/2019
Event Type  Death  
Event Description

The manufacturer received information alleging an oxygen concentrator was provided to the patient without the device instructions of use. The patient expired. The device is not life supporting or life sustaining. Repeated attempts to have the returned for evaluation and investigation were unsuccessful. The manufacturer believes they will be unable to gather additional information. The manufacturer is submitting a final report at this time. If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

 
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Brand NameSIMPLYGO MINI
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068
Manufacturer (Section G)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068
Manufacturer Contact
adam price
312 alvin drive
new kensington , PA 15068
7243349303
MDR Report Key9564253
Report Number2518422-2020-00062
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received12/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2019
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: 01/08/2020 Patient Sequence Number: 1
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