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

Model Number 900-000

Device Problem Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/16/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging an evergo oxygen concentrator stopped working while on a plane.The patient was given supplemental oxygen by the airline.The patient went to the emergency room and was sent home.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an oxygen concentrator allegedly stopped working while on a plane.The patient was given supplemental oxygen by the airline.The patient went to the emergency room and was sent home.The durable medical equipment (dme) supplier reported that the device was tested at their facility.A faulty power cord was confirmed.The power cord was replaced.The device is not returning to the manufacturer for service.

• Brand Name: EVERGO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 9082797
• MDR Text Key: 159032917
• Report Number: 1040777-2019-00043
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K043615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900-000
• Device Catalogue Number: 900-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization