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

Model Number	1068987
Medical Device Problem Codes	Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a simplygo oxygen concentrator device.The patient alleges that on the way home, the patient began to smell an electrical burning odor.The patient alleges the smell was stronger and the device was smoking upon reaching home.The patient did not observe any flames and did not see evidence of melting, warping, or any voids in the device enclosure.Also, the power cord was not damaged.At the time of the event, the device was using battery power.There was no property damage beyond the device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information in reference to a simplygo oxygen concentrator device.The patient alleges that on the way home, the patient began to smell an electrical burning odor.The patient alleges the smell was stronger and the device was smoking upon reaching home.The patient did not observe any flames and did not see evidence of melting, warping, or any voids in the device enclosure.Also, the power cord was not damaged.At the time of the event, the device was using battery power.There was no property damage beyond the device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Update: capa was previously initiated for similar incidents and is being monitored for any emerging trends.
Additional Manufacturer Narrative
Device evaluation information was received on 10/24/2024, and section h10 should be reported as: the manufacturer was contacted in reference to a simplygo oxygen concentrator device.The patient alleges that on the way home, the patient began to smell an electrical burning odor.The patient alleges the smell was stronger and the device was smoking upon reaching home.The patient did not observe any flames and did not see evidence of melting, warping, or any voids in the device enclosure.Also, the power cord was not damaged.At the time of the event, the device was using battery power.There was no property damage beyond the device.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed plastic warping/carbon on unit enclosure.Unit forwarded to oxygen engineering (jh,) for engineering support into this allegation.And allegation was confirmed.In box h: evaluation method code, evaluation results code, component code grid and conclusion code grid has been updated in this report.

• Brand Name: SIMPLYGO
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17840182
• Report Number: 2518422-2023-24411
• Device Sequence Number: 7770351
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 06/24/2024; 10/24/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 09/12/2024; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male