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

Model Number	1020020
Medical Device Problem Codes	No Audible Alarm (1019); Failure to Deliver (2338)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator had no flow and did not alarm.The patient went to the hospital for one night.The device was evaluated by a third party service center.The customer's complaint was not confirmed.The device was found to operate and alarm to specifications.The device was found to be contaminated.
Additional Manufacturer Narrative
The manufacturer previously reported the awareness date was (b)(6) 2018.The correct awareness date is (b)(6) 2018.

• Brand Name: EVERFLO OPI OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7703750
• Report Number: 1040777-2018-00031
• Device Sequence Number: 11408193
• Product Code: CAW
• UDI-Device Identifier: 00606959032774
• UDI-Public: 00606959032774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1020020
• Device Catalogue Number: 1020020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization