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

Model Number 1020001

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/21/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator alarmed and shut down while in patient use.The patient was hospitalized.The device has yet to be returned to the manufacturer's service center for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an everflo oxygen concentrator allegedly alarmed and shut down while in patient use.The patient was hospitalized.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was confirmed.The device's compressor was locked.The compressor will need replaced to address the issue.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668 3724
• Manufacturer (Section G): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7658793
• MDR Text Key: 113043975
• Report Number: 1040777-2018-00027
• 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: 06/28/2018

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: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2012
• 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
• Patient Age: 89 YR