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

Model Number	M10600
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/28/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received a voluntary medwatch (mw5107134) alleging a millennium oxygen concentrator stopped working and did not alarm.The patient's blood oxygen level decreased and was placed on a back up supply of oxygen.The patient did not recover from the event and expired a few days later.The device is not returning to the manufacturer for evaluation.The device is currently being used by another patient.
Additional Manufacturer Narrative
The manufacturer previously received information alleging ventilator inoperative condition occurred related to a ventilator device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.
Additional Manufacturer Narrative
In the previous report section h10 was incorrectly captured, it should have been reported as: the manufacturer previously received a voluntary medwatch (mw5107134) alleging a millennium oxygen concentrator stopped working anddid not alarm.The patient's blood oxygen level decreased and was placed on a back up supply of oxygen.The patient did not recover from the event and expired a few days later.The device is not reutrning to the manufacturer for evaluation.The device is currently being used by another patient.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14606055
• Report Number: 2518422-2022-29494
• Device Sequence Number: 4346721
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K043006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2022
• Supplement Date Received by Manufacturer: 07/26/2023; 09/15/2023
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/28/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2004
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female