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

Model Number 1020002

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem Death (1802)

Event Date 12/07/2017

Event Type  Death  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator was not working properly and the patient expired.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 alleged was not working properly and the patient expired.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• 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: 7121116
• MDR Text Key: 94965497
• Report Number: 1040777-2017-00041
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032514
• UDI-Public: 00606959032514
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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: 1020002
• Device Catalogue Number: 1020002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2008
• 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: 58 YR