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

Model Number 1020000

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/24/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator was emitting an odor and was not working correctly.The patient was admitted to the hospital.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an everflo oxygen concentrator that allegedly was emitting an odor and was not working correctly.The patient was admitted to the hospital.The device was returned to the manufacturer's service center for evaluation.The device ws tested and was found to deliver oxygen to design specifications.There was no evidence of a burning odor being emitted by the device and there was no evidence of thermal damage to the device.The manufacturer concludes the device did not cause or contribute to the patient's hospitalization.

• Brand Name: EVERFLO OXYGEN CONCENTATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8879612
• MDR Text Key: 153851565
• Report Number: 1040777-2019-00038
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization