MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO INTERNATIONAL; STATIONARY OXYGEN CONCENTRATOR

Model Number 1020007

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a thermal event to an everflo international oxygen concentrator.The patient reported that fire has come out of the unit, and it now smells burnt.There was no report of serious patient harm.There was no report of medical intervention.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

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported an allegation of a thermal event to an everflo international oxygen concentrator.The patient reported that fire had come out of the unit, and it smelled burnt.There was no report of serious patient harm.There was no report of medical intervention.The device was evaluated by the product investigation lab.During evaluation, no evidence of a thermal event could be confirmed.The unit was returned with significant physical damage, specifically to the power cord due to customer abuse.It was determined the unit had been repeatedly constrained against a flat surface, and the continuous bending has fatigued the wires to the point of failure, rendering the unit unable to be placed into service/use.Any perceived customer allegation of a thermal event is concluded as being indicative of the ac power cord conductors shorting to one another, and immediately creating an open condition.Additionally, letter was sent to the customer to make them aware of investigative findings.

• Brand Name: EVERFLO INTERNATIONAL
• Type of Device: STATIONARY OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17701954
• MDR Text Key: 322879007
• Report Number: 2518422-2023-21988
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: 00606959032569
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1