MAUDE Adverse Event Report: DEVILBISS HEALTHCARE, LLC 525DS OXYGEN CONCENTRATOR

Model Number 525DS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

We are still in the process of obtaining additional details regarding the event.We are currently in contact with the initial reporter to obtain additional information regarding the event and any initial reports that they might have regarding the incident.Unit evaluation: the 525ds oxygen concentrator, serial number (b)(4) was returned for evaluation on 6/19/2017.During the initial performance assessment, which included plugging the unit into ac power and turning it on, upon start-up the "service required" light illuminated and the audible alarmed sounded.The unit was opened to assess internal components and potential cause of the fault mode/alarm condition.The cause of the fault mode/alarm was a small amount of sieve material from the right sieve bed had leaked into the rotary valve, causing the valve to stick.This condition triggers a designed fault condition that causes the unit to shut down and provide an audible and visual alarm to the user.The investigation revealed the root cause of the failure to be an incorrectly installed filter in the right sieve bed, the result of which caused sieve material to leak out of the sieve bed and into the valve.The 525ds oxygen concentrator performed as designed and entered the fault mode, which shuts the unit off and alarms both audibly and visually to alert the patient and/or caregivers to take appropriate actions as outlined in the user manual.Oxygen concentrators are designed to provide supplemental oxygen therapy and not intended to be life supporting or life sustaining.As electromechanical devices, oxygen concentrators are impacted by loss of power, as well as potential for component or device failure; all of which are elements of the device risk and hazard analysis.Patients requiring supplemental oxygen therapy have chronic lung disease and other chronic medical conditions contributing to chronic hypoxemia.Supplemental oxygen used in the treatment of chronic hypoxemia is not a life supporting or life sustaining therapy.Oxygen therapy in the home or not hospital setting is intended as a long term, supplemental treatment for which the consistent use of a prescribed flow of oxygen for less or equal to 15 hours per day, over a long period of time may improve life expectancy in certain patient populations with chronic lung disease and chronic resting hypoxemia.Mitigation of potential oxygen delivery failure are outlined in the user manual and supported by the home oxygen service providers.These include but are not limited to the following: this concentrator generates supplemental oxygen for use on order of a physician or healthcare provider.Oxygen concentrator intended use is to provide supplemental low flow oxygen therapy for patients suffering from copd, cardiovascular disease, and lung disorders the oxygen concentrator is used in home type environments, homes, nursing homes, patient care facilities, etc if you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm.Geriatric, pediatric or any other patient unable to communicate discomfort can require additional monitoring and/or a distributed alarm system to convey the information about the discomfort and/or the medical urgency to the responsible caregiver to avoid harm.As a precaution, your devilbiss provider may supply you with a reserve oxygen system if your unit loses electrical power or fails to operate correctly, the patient alert system will sound to signal you to switch to your reserve oxygen system (if provided) and contact your devilbiss provider.Note- if the service required light illuminates and the audible signal alarms but the unit is not operating, there is no power to the unit.Refer to the minor troubleshooting chart and contact your (b)(4) provider if necessary.Home oxygen service providers are required to be available twenty-four hours per day to support home oxygen patients in the event of oxygen device concerns or failures, including prolonged power outages.Home oxygen accreditation agencies (the joint commission, chap, achc, etc.) require providers to supply a back-up source of oxygen (i.E., compressed oxygen cylinders) to any electrically powered oxygen system.Nocturnal oxygen therapy trial group.Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial.Ann intern med 1980;93(3): 391-398.Global strategy for the diagnosis, management, and prevention of copd, 2017 revision.Global initiative for chronic lung disease.Accessed via web at (b)(4), may 2017.

Event Description

(b)(4) received notice of an incident involving an oxygen concentrator that (b)(4) imports and distributes.The information provided regarding this complaint "stated the patient was staying in a hospice and using the oxygen concentrator when allegedly the unit failed overnight and the patient died." there was no other information regarding the patient or the device provided, including any specific information correlating the alleged device failure and the patient's death.Oxygen concentrators are designed to provide supplemental oxygen therapy and not intended to be life supporting or life sustaining.As part of our investigation, we have contact the initial complainant for additional information and are awaiting their reply.

• Brand Name: 525DS OXYGEN CONCENTRATOR
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): DEVILBISS HEALTHCARE, LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE, LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: betty miller ; 100 devilbiss drive; somerset, PA 15501 ; 8144437602
• MDR Report Key: 6695660
• MDR Text Key: 79352726
• Report Number: 2515872-2017-00003
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: 00885304000846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: 525DS
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death