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

Model Number	M10605
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleginga millennium oxygen concentrator shut off without an alarm.The patient was taken to the hospital by ambulance.The patient was diagnosed with bacterial pneumonia and placed on a ventilator.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The device was visually inspected and was found to have evidence of physical damage.The device was tested and was found to provide therapy properly.The customer's complaint of the device not alarming was confirmed.The technician found the 9volt battery used to power the loss of power alarm source was depleted, causing the device to not alarm if ac power was lost.Product labeling states,"if the device is turned on but not operating, the alarm condition will be activiated.This is often the result of either the device not being plugged in or a power failure.The feature is powered by an internal 9v battery.To test the condition of the battery you should test this alarm state often by unplugging the device and switching the power on.If the alarm condition is not activated, you should contact your home care provider to replace the battery.".

• Brand Name: MILLENNIUM OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13316151
• Report Number: 2518422-2022-00885
• Device Sequence Number: 17333512
• Product Code: CAW
• UDI-Device Identifier: 00606959015685
• UDI-Public: 00606959015685
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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: Health Professional
• Device Model Number: M10605
• Device Catalogue Number: M10605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2014
• 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: Hospitalization
• Patient Sex: Male