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	Low Oxygen Saturation (2477); No Information (3190)
Date of Event	08/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a simplygo oxygen concentrator was not working properly and was not 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 submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a simplygo oxygen concentrator allegedly was not working properly and was not alarming.The patient was admitted to the hospital.The manufacturer received information from the durable medical equipment (dme) supplier that the device was returned to their facility and was tested.The device passed all testing and was placed in the dme's inventory.The device is not returning to the manufacturer for evaluation.The dme also reported the patient's admission to the hospital was due to his illness and was not caused by the device.

• 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: 6829976
• Report Number: 1040777-2017-00028
• Device Sequence Number: 41214
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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: 08/08/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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: 89 YR