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

Model Number 1020008

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator had thermal damage to the power cord.There was no report of patient harm or injury.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 evidence of thermal damage to the power cord.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.The manufacturer found evidence of thermal damage to the power cord.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 caused the power cord to bend, creating weakness in the power cord.Product labeling for the everflo oxygen concentrator states, "keep the device at least 15-30cm 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)." "do not use the oxygen concentrator if either the plug or power cord is damaged.".

Manufacturer Narrative

The manufacturer previously reported that the device was not returned to the manufacturer incorrectly.The device was returned to the manufacturer for evaluation.

• 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: 8069176
• MDR Text Key: 127230362
• Report Number: 1040777-2018-00047
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: 00606959032576
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• 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