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

Model Number 1020001

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problems Pneumonia (2011); No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator had low oxygen concentration and was alarming.The patient was admitted to the hospital.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an everflo oxygen concentrator allegedly had low oxygen concentration and was alarming.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The manufacturer found the compressor bearing to have failed.The compressor was replaced to address the issue.

• 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: 7270683
• MDR Text Key: 100071625
• Report Number: 1040777-2018-00005
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: 00606959022041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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): Hospitalization