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

Model Number 1020007

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer.

Event Description

The manufacturer became aware that a user of oxygen was visited by emergency services and reported that the oxygen nasal cannula had begun to burn.The unit was replaced, and the patient is reported as being "well." the patient denied having smoked a cigarette; however, a cigarette was retrieved by the fire department who stated that was the cause.The user was informed of the warning and safety instructions and the special fire hazard when using oxygen.Additional adhesive warning labels were also attached to the unit.The unit was inspected, and no traces of fire were found on or in the unit.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: EVERFLO CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• 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: 17505456
• MDR Text Key: 320910616
• Report Number: 2518422-2023-19393
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: 00606959032569
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1