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

Model Number	1113605
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient was hospitalized with pulmonary embolism allegedly caused by the simplygo mini oxygen concentrator.The medical treatment is unknown.There was no allegation of device malfunction.The device is not returning to the manufacturer for evaluation.The sales office checked the device and found the device to operate with no issues.
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 1670.Section h6 has been updated with the correct information.

• Brand Name: SIMPLLYGO MINI 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: 13093602
• Report Number: 2518422-2021-08747
• Device Sequence Number: 13955201
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: 00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: Hospitalization
• Patient Sex: Unknown