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

Model Number	1133943
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient's blood oxygen level was 70% and not increasing when using the simplygo mini oxygen concentrator.The patient was placed on hospital oxygen and was then provided a new device.The patient's blood oxygen level recovered.The device was returned to the manufacturer's service center for evaluation.The manufacturer found the device to have a system alarm and sieve alarm logged.The compressor and sieve canister were replaced to address the issue.A leak was found during the evaluation, the sieve o2 assembly was replaced to address the issue.The device is not a life sustaining or life supporting.Product labeling states,"the oxygen delivery settings of the oxygen concentrator should be periodically reassessed for the effectiveness of the therapy.".

• Brand Name: SIMPLYGO MINI
• 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.; 6501 living place; pittsburgh PA 15206
• Manufacturer Contact: rod mell ; 6501 living place; pittsburgh, PA 15206
• MDR Report Key: 12756404
• Report Number: 2518422-2021-06308
• Device Sequence Number: 4254863
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: 00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2018
• 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: Required Intervention
• Patient Sex: Unknown