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

Model Number	1133943
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging the power cord inlet broke and the power cord failed to be put in.There is no report of exposed conducting wiring.This issue would not increase risk to the intended user or caregiver.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
A device was returned to a third-party service center and during the evaluation the device was visually inspected and found evidence that the power connector is damaged and needs to be replaced, an internal leak was confirmed during inspection, the shive o2 side assembly requires replacement and an abnormal noise during operation check was observed, and the air side manifold needs replacement.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received information alleging the power cord inlet broke and the power cord failed to be put in.There is no report of exposed conducting wiring.This issue would not increase risk to the intended user or caregiver.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.**udi related data quality updates only** the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• Brand Name: SIMPLYGO MINI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• 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: 17851049
• Report Number: 2518422-2023-24831
• Device Sequence Number: 3278219
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: (01)00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,User Facility
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 03/21/2024; 08/02/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 04/10/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2020
• 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