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

Model Number 1020000

Device Problem Device Emits Odor (1425)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation conclusion: the device was not returned for evaluation since the device was scrapped by the (b)(4).

Event Description

The manufacturer received information alleging a patient had smoke inhalation while using an everflo oxygen concentrator.The patient went to the emergency room but it is unknown what medical treatment was required.Based on the information from the reporting facility, the patient notified the (b)(4)) supplier on (b)(6) 2017 that the device was reportedly emitting a burning odor.The (b)(4) replaced the device and scrapped the device that was allegedly emitting a burning odor.The (b)(4) was unaware of the patient allegation until a couple of weeks after the device was scrapped.According to the (b)(4), the patient is currently using the replacement device and suffered no permanent harm or injury.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 6837599
• MDR Text Key: 84324131
• Report Number: 1040777-2017-00029
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/10/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR