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

Model Number	1113607
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted about a simplygo mini stand battery ikk device due to reports of it smoking.The service center has received the device for evaluation.Importantly, there are no claims of patient harm or serious injury, and no medical intervention has been specified.The manufacturer's investigation is still in progress.If any additional relevant information comes in, a follow up report will be submitted.
Additional Manufacturer Narrative
The manufacturer was previously contacted regarding a simplygo mini stand battery ikk device due to reports of it smoking.The device was received at the third-party service center for inspection, and the evaluation notes indicate that the customer's complaint regarding a "smoking device/preparation" could not be reproduced.However, the assessment revealed several issues: the sieves were clogged, and there were air leaks on both the air and o2 sides of the device.Additionally, the inlet filter needed to be replaced for preventive maintenance, and the rp-simplygo mini alarm/tilt sensor was missing.Despite the initial complaint not being replicated, the device was repaired.Following these actions, the device has been serviced, inspected, and tested and has met all acceptance criteria in accordance with the applicable customer requirements as defined in the contractual agreement with the third-party service center.
Additional Manufacturer Narrative
The manufacturer was previously notified about a complaint regarding the device smoking.A field service technician then inspected the device, replaced the necessary components identified during the evaluation, and restored the device to full operational functionality.Although the technician was unable to replicate the reported issue and no relevant reportable information was received, a follow-up report was mistakenly filed without the appropriate coding.This has now been corrected in this report, and the correct coding has been added.

• Brand Name: SIMPLYGO MINI,STND BATTERY,IKK
• 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: 21982161
• Report Number: 2518422-2025-105284
• Device Sequence Number: 18220935
• Product Code: CAW
• UDI-Device Identifier: 00606959033825
• UDI-Public: (01)00606959033825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/15/2025

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: 1113607
• Device Catalogue Number: 1113607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 05/20/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/28/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown