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

Model Number 1020020

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Date 09/27/2018

Event Type  Death  

Event Description

The manufacturer received information alleging a patient expired while using an everflo oxygen concentrator with a ventilator.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 a patient allegedly expired while using an everflo oxygen concentrator with a ventilator.The device was returned to a third party service center for evaluation.The device was tested and was found to operate and alarm to design specifications.The manufacture concludes the device did not cause or contribute to the patient's death.

• 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: 7929997
• MDR Text Key: 122497642
• Report Number: 1040777-2018-00040
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032774
• UDI-Public: 00606959032774
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020020
• Device Catalogue Number: 1020020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2017
• 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: 84 YR