MAUDE Adverse Event Report: RESPIRONICS INC. OXYGEN CONCENTRATOR 10LITER; GENERATOR, OXYGEN, PORTABLE

Model Number M10

Device Problems Loose or Intermittent Connection (1371); Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Patient was smoking while on the oxygen concentrator.The nasal canula melted and patient rushed to the emergency room (er).Tech checked out the concentrator and found no issues.Plug was loose so he moved the concentrator to a different plug and redirected the family that they are not to smoke anywhere near the concentrator and urged them to go outside.Before pictures we made the family remove the ash trays.The house smelled heavy with cigarette smoke (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OXYGEN CONCENTRATOR 10LITER
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 17527617
• MDR Text Key: 321446286
• Report Number: MW5134549
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: M10
• Patient Sequence Number: 1