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

Model Number M10600

Device Problem No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Death  

Event 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.

• Brand Name: MILLENNIUM M10 OXYGEN CONCENTRATOR
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16196503
• MDR Text Key: 307609736
• Report Number: 2518422-2023-02027
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Female