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

Model Number	1069058
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The device power supply was found to have scorch marks on ribbon cable.The device was unrepairable.Although there was no patient harm or injury, this event is reportable due to a potential to cause or contribute to a serious injury.A report will be filed with all applicable regulatory agencies.
Additional Manufacturer Narrative
The event problem in the b5 was updated to: the device was found to have scorch marks on the ribbon cable.The device was unrepairable.Although there was no patient harm or injury, this event is reportable due to a potential to cause or contribute to a serious injury.A report will be filed with all applicable regulatory agencies.The device problem code grid problem code l2, l3, and the device problem fda c-code were updated.
Event or Problem Description
The device was found to have scorch marks on the ribbon cable.The device was unrepairable.Although there was no patient harm or injury, this event is reportable due to a potential to cause or contribute to a serious injury.A report will be filed with all applicable regulatory agencies.

• Brand Name: SIMPLYGO
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20287867
• Report Number: 2518422-2024-100927
• Device Sequence Number: 17941897
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: 00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2020
• 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 Sex: Unknown