MAUDE Adverse Event Report: CAIRE INC. COMPANION 5; CONCENTRATOR, OXYGEN, STATIONARY

Model Number	15067005
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The machine in question is not a life supporting device.It is used for oxygen therapy.The unit was returned displaying alarm code al-p08, indicating low oxygen.The user manual instructs the user to not ignore the alarm, to switch to the backup source of oxygen, and to notify the healthcare provider immediately.A back up source of oxygen is recommended per user manual.The unit showed the sieve dust being expelled from the outlet barb, suggesting that the unit was allowed to run while alarming for an extended amount of time.The machine will show yellow led lights and the alarm will sound when there is a malfunction.Due to expected movement of the sieve material (zeolyte) in the sieve bed, after a long period of time a mechanical breakdown causes the material to break down into dust-size particles which, by design, are blocked by subsequent filters in the gas pathways which causes gas purity alarms (alpl08).In the current case, as the alarm was ignored for a long time, a very small amount of sieve dust could slowly penetrate through the filter.The inspection of the device revealed that there was an outlet gas filter failure.The risk assessment associated with this device indicates the risk and hazard of the filter failure as a low.No trend is detected at this time and the occurrence threshold has not been exceeded.The most recent analysis showed the occurrence of this event to below at.016%.Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.
Event or Problem Description
The unit was returned displaying alarm code al-p08, indicating low oxygen.The user manual instructs the user to not ignore the alarm, to switch to the backup source of oxygen, and to notify the healthcare provider immediately.A backup source of oxygen is recommended per user manual.The unit showed the sieve dust being expelled from the outlet barb, suggesting that the unit was allowed to run while alarming for an extended amount of time.

• Brand Name: COMPANION 5
• Common Device Name: CONCENTRATOR, OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: pamela netzel ; 2200 airport industrial drive; suite 500; ball ground, GA 30107
• MDR Report Key: 20529467
• Report Number: 3004972304-2024-00012
• Device Sequence Number: 21108527
• Product Code: CAW
• UDI-Device Identifier: M766150670050
• UDI-Public: +M766150670050/16D20240215W
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 15067005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male