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U.S. Department of Health and Human Services

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

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RESPIRONICS EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020001
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 06/21/2018
Event Type  Injury  
Event Description
The manufacturer received information alleging an everflo oxygen concentrator alarmed and shut down while in patient use.The patient was hospitalized.The device has yet to be returned to the manufacturer's service center for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
 
Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator allegedly alarmed and shut down while in patient use.The patient was hospitalized.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The device's compressor was locked.The compressor will need replaced to address the issue.
 
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Brand Name
EVERFLO OXYGEN CONCENTRATOR
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS
1001 murry ridge lane
murrysville PA 15668 3724
Manufacturer (Section G)
RESPIRONICS
1001 murry ridge lane
murrysville PA 15668 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key7658793
MDR Text Key113043975
Report Number1040777-2018-00027
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 06/28/2018
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 Manufacturer07/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/28/2018
Initial Date FDA Received07/03/2018
Supplement Dates Manufacturer Received07/30/2018
Supplement Dates FDA Received08/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2012
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;
Patient Age89 YR
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