MAUDE Adverse Event Report: RESPIRONICS, INC. MILLENNIUM M10 OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	M10600
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a millennium m10 oxygen concentrator had a yellow light but not alarming and the device's oxygen concentration was at 72%.The patient expired while using the device.The device has yet to be returned to the manufacturer's product investigation laboratory for further investigation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
In this report, box b: adverse event or product problem (describe event or problem) as the manufacturer received information alleging a millennium m10 oxygen concentrator had a yellow light but not alarming and the device's oxygen concentration was at 72%.The patient expired while using the device.No medical intervention was required by the patient.The device was returned to the manufacturer product investigation laboratory for investigation and investigated.Result stated unit compressor outlet (blue hose that supplies the compressed air to the sieve cannister,) appears to have been damaged/sliced or cut during 3rd party service installation of the one-eared clamp under ra: (b)(4).This failure mode creates a system leak/low flow and fluctuating low oxygen concentration level when the unit is utilized above 6 lpm (adjusted user flow meter setting.) the system is unable to maintain a proper pressure for high flow concentration.The unit functions and provides appropriate therapy at 5 lpm and below, however oxygen percentage drops out above that 5 lpm thresh-hold.Furthermore, this unit does not alarm properly (within 60 seconds,) when a no flow/low flow condition exists, because a fluctuating flow still exists, but is escaping from the damaged supply tubing.This condition/damage would prevent both proper oxygen therapy and an alarming condition under appropriate clinical circumstances requiring an alarm notification.The manufacturer is submitting a final report at this time.If any additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed, box d: suspect medical device (operator of device), box g: all manufacturers (report source), box h: device manufacturers (evaluation method code grid, evaluation results code grid, conclusion code grid) have been corrected/updated.

• Brand Name: MILLENNIUM M10 OXYGEN CONCENTRATOR
• 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: 16196503
• Report Number: 2518422-2023-02027
• Device Sequence Number: 4385939
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: Other
• Device Model Number: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female