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

Model Number 1020006

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2017

Event Type  malfunction  

Event Description

The manufacturer received information alleging the everflo oxygen concentrator had evidence of thermal damage to the power cord.There was no report of patient harm or injury.The device was returned to the manufacturer' service center for evaluation.The customer's complaint was confirmed.The manufacturer found the power cord had evidence of thermal damage to the outer cover.There was no evidence of exposed copper wires.The power cord was observed to have damage consistent with the application of excessive force by the end user.It appears the device was placed too close to a hard surface.This cause the power cord to be bend, creating weakness in the power cord.Product labeling for the everflo oxygen concentrator state, "keep the device at least 15 to 30 cm away from walls, furniture, and especially curtains that could impede adequate airflow to the device.Do not place the concentrator in a small closed space (such as a closet).".

• 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: 6784242
• MDR Text Key: 82512511
• Report Number: 1040777-2017-00025
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: 00606959032552
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2012
• 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