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

Model Number	1068987
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a simplygo oxygen concentrator shut down while in patient use.The patient fainted and was taken to the hospital and placed on life support.The patient was in the hospital for 6 days.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 allegedly shut down while in patient use.The patient fainted and was taken to the hospital and placed on life support.The patient was in the hospital for 6 days.The device was returned to the manufacturer for evaluation.The customer's complaint was confirmed.The device shut down due to increased pressure within the sieve canisters.The sieve was replaced to address the issue.

• 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: 8282209
• Report Number: 1040777-2019-00006
• Device Sequence Number: 2056995
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR