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

Model Number	M10605-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/05/2018
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a millennium m10 oxygen concentrator was not working properly.The patient became hypoxic and was taken to the hospital by ambulance where she later expired.The device is not returning to the manufacturer at this time.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a millennium m10 oxygen concentrator was allegedly not working properly.The patient became hypoxic and was taken to the hospital by ambulance where she later died.The device was returned to the durable medical equipment (dme) supplier and was tested.The dme found the device to operate and alarm to design specifications.

• Brand Name: MILLENNIUM M10
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8173952
• Report Number: 1040777-2018-00049
• Device Sequence Number: 2792608
• Product Code: CAW
• UDI-Device Identifier: 00606959012776
• UDI-Public: 00606959012776
• 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: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M10605-10
• Device Catalogue Number: M10605-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: 89 YR