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

Model Number	1068987
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Code Available (3191)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a simplygo oxygen concentrator was not producing oxygen.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.
Additional Manufacturer Narrative
The manufacturer previously reported a simplygo oxygen concentrator was not producing oxygen and the patient was admitted to the hospital.The patient reportedly had a heart attack and cardiopulmonary resuscitation was performed.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.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7049011
• Report Number: 1040777-2017-00036
• Device Sequence Number: 10988716
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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
• Patient Age: 71 YR