MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC MILLENNIUM OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number M605

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 01/21/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient was smoking a cigarette while using a millennium oxygen concentrator.The patient received burns to his face and hands and is currently hospitalized for treatment of the burns.

Manufacturer Narrative

The reporting facility confirmed the device is not being returned for evaluation.Based on the available information, the patient lit a cigarette while using the oxygen concentrator.Product labeling states, "do not smoke, allow others to smoke or have open flames near the concentrator when in use.".

• Brand Name: MILLENNIUM OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC; 175 chastain meadows ct; kennesaw GA 30144 372
• Manufacturer (Section G): RESPIRONICS, INC; 175 chastain meadows court; kennesaw GA 30144 372
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville 15146 ; 7243875658
• MDR Report Key: 4517240
• MDR Text Key: 16557880
• Report Number: 1040777-2015-00006
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M605
• Device Catalogue Number: M605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2006
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR