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

Model Number	M10600
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the device caught on fire and burned the patient.The patient's representative reported there was no smoking, and the patient did report to the emergency room with reported burns.Medical intervention was not specified.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
H3 other text : device not retuned to manufacture.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice.The manufacturer received information alleging the millennium m10 concentrator device caught on fire and burned the patient.The patient's representative reported there was no smoking, and the patient did report to the emergency room with reported burns.Medical intervention was not specified.A correction was made to the b5 event or problem description.The device was mistakenly reported as a recall however this is a concentrator.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice.The manufacturer received information alleging the millennium m10 concentrator device caught on fire and burned the patient.The patient's representative reported there was no smoking, and the patient did report to the emergency room with reported burns.Medical intervention was not specified.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: MILLENNIUM M10 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: 19078601
• Report Number: 2518422-2024-18633
• Device Sequence Number: 20502443
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2022
• 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: Other
• Patient Sex: Male