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

Model Number 1020006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/21/2019

Event Type  Death  

Event Description

The manufacturer received information alleging a patient expired while using an everflo oxygen concentrator.There was no allegation of a device malfunction.The device is not returning to the manufacturer for evaluation.Based on the available information, the everflo oxygen concentrator was being used with a nasal cannula on a patient with a tracheostomy.The nasal cannula was placed beside the patient when the patient expired.The manufacturer concludes there was no allegation of a device malfunction.This appears to have been caused by use error.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR OPI
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• 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: 8374129
• MDR Text Key: 137271364
• Report Number: 1040777-2019-00010
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: 00606959032552
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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
• Patient Age: 11 MO