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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE
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PHILIPS RESPIRONICS INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020000
Device Problem Fire (1245)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2016
Event Type  malfunction  
Event Description
The manufacturer received information alleging an everflo oxygen concentrator was involved in a house fire.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.
 
Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly involved in a house fire.There was no report of patient harm or injury.Repeated attempts to have the device 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 Name
EVERFLO OXYGEN CONCENTRATOR
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
312 alvin drive
new kensington PA 15068 3724
MDR Report Key8939956
MDR Text Key155820661
Report Number1040777-2019-00039
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K061261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1020000
Device Catalogue Number1020000
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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