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

Model Number	1068987
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received the information alleging a simplygo oxygen concentrator stop providing oxygen while in patient use.The pateint's blood oxygen level decreased.The patient went to emergency room and was provided oxygen.The device has yet to be returned 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 stop providing oxygen while in patient use.The pateint's blood oxygen level decreased.The patient went to emergency room and was provided oxygen.The device was returned to the manufacturer's product invesigation laboratory for investigation.The customer's complaint was unable to be confirmed.The device was tested and was found to operate to design specifications.The manufacturer concludes the device did not cause or contribute to the reported event.
Additional Manufacturer Narrative
The manufacturer previously reported the medical device problem code as 2993 in section h6, the correct medical device problem code in section h6 is 4019.Section h6 has been updated with the correct information.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15208701
• Report Number: 2518422-2022-70797
• Device Sequence Number: 2123077
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 12/06/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/07/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female