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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

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RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020001
Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Patient Problems Pneumonia (2011); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2018
Event Type  Injury  
Event Description
The manufacturer received information alleging an everflo oxygen concentrator had low oxygen concentration and was alarming.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 filed when the manufacturer has completed the investigation.
 
Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator allegedly had low oxygen concentration and was alarming.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The manufacturer found the compressor bearing to have failed.The compressor was replaced to address the issue.
 
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Brand Name
EVERFLO OXYGEN CONCENTRATOR
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer (Section G)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key7270683
MDR Text Key100071625
Report Number1040777-2018-00005
Device Sequence Number1
Product Code CAW
UDI-Device Identifier00606959022041
UDI-Public00606959022041
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1020001
Device Catalogue Number1020001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/08/2018
Initial Date FDA Received02/14/2018
Supplement Dates Manufacturer Received03/28/2018
Supplement Dates FDA Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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