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

Model Number	1113601
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the simplygo mini device had a yellow alarm displayed, and the unit got hot and turned off.The customer alleged the device malfunction caused her oxygen to drop to 56 and her lips to turn black (hypoxia).No medical intervention was reported.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
The customer reported that the simplygo mini device had a yellow alarm displayed, and the unit got hot and turned off.The customer alleged the device malfunction caused her oxygen to drop to 56 and her lips to turn black (hypoxia), which cannot be confirmed, nor refuted, based on the evidence present.No medical intervention was reported.Of note, this device is not intended to be life-sustaining or life-supporting.The device was forwarded and returned to the product investigation lab (pil) for evaluation.The pil was unable to replicate the yellow alarm, unit shuts off, and unit gets hot.Unit performed as intended.However, pil was able to confirm the unit had sieve health replace, motor rpm increased (hot), very low o2 entries in the event log on the date of occurrence stated in the complaint.These entries and the physical condition of the unit upon arrival are indicative of an occlusion caused by a buildup of dust.The device was scrapped.
Additional Manufacturer Narrative
Based on the information currently provided and available, it was alleged that when the device is on the patient's back it gets really hot and then shuts off.The device then has a yellow alarm display on the screen.The patient¿s spo2 dropping to 56% and her lips turning black.This adverse event has been assessed as a serious injury with a harm severity 3.According to the lab investigation performed, pil was unable to replicate failure/allegation.Pil was able to confirm the unit had sieve health replace, motor rpm increased (hot), very low o2 entries in the event log on the date of occurrence stated in the complaint.Cause and contribution of the device to the patient outcome has been confirmed.Further review of er 2246289 v08 oxygen product safety risk management matrix - current revision has linked the event to risk tag id 13.1.The predicted severity associated with this risk tag is congruent with the allegation of harm as severity 3.No additional actions are required nor any further escalation.

• Brand Name: SIMPLYGO MINI
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20518066
• Report Number: 2518422-2024-102532
• Device Sequence Number: 8724841
• Product Code: CAW
• UDI-Device Identifier: 00606959032392
• UDI-Public: (01)00606959032392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/08/2025; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Female