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U.S. Department of Health and Human Services

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

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PHILIPS RESPIRONICS INC. HEALTHDYNE ALLIANCE OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Device Problem Use of Device Problem
Event Date 10/27/2014
Event Type  Death  
Event Description

The manufacturer received information alleging a healthdyne alliance oxygen concentrator did not provide oxygen to the patient. It was reported that the humidifier bottle was not connected correctly. The patient expired. The investigation is still ongoing. A follow up report will be submitted when the manufacturer has completed the investigation.

 
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Brand NameHEALTHDYNE ALLIANCE 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 Key8837277
Report Number1040777-2019-00037
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/29/2019 Patient Sequence Number: 1
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