MAUDE Adverse Event Report: RESPIRONICS INC. RESPIRONICS, MILLENNIUM M10, OXYGEN CONCENTRATOR WITH 10L FLO; GENERATOR, OXYGEN, PORTABLE

Model Number M10

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problems Anxiety (2328); Depression (2361); Superficial (First Degree) Burn (2685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/28/2022

Event Type  Injury  

Event Description

Adverse event oxygen safety incident report.(b)(6) 2022 a 62-year-old female with terminal copd and oxygen dependence knowingly lit a cigarette approximately 11am while consuming oxygen via nasal cannula which resulted in an explosion of a millennium m10 oxygen concentrator.Patient remained conscious, fire was extinguished immediately by family members on site and patient was transported via ems to (b)(6) hospital.Patient acknowledged her actions, stated she was aware that there were no witnesses and had lit the cigarette as she was feeling increased anxiety and depression due to multiple psychosocial factors, including terminal health conditions that limit her ability to participate in the thanksgiving holiday event and news of her car being totaled by her grandson.Patient has been on supplemental oxygen for months; she was admitted for hospice services (b)(6) 2022.She was trained upon hospice admission regarding oxygen safety and training was refreshed when oxygen concentrator was delivered.Family members do not smoke, and only patient's boyfriend is known smoker who is instructed to smoke outdoors.Patient herself had stopped smoking prior to hospice admission and stated, she did it in a moment of weakness, she stated she did not expect complications from a "small bud".Patient was discharged from hospital er same day, and returned home in a few hours of the incident, her burns are determined as first degree per discharge documentation shared by patient and hospitalist has noted that she can be adequately managed at home.Patient and all caregivers re-educated by hospice physician prior to discharge (b)(6) 2022 and hospice rn continues teaching during daily follow-ups.Oxygen concentrator returned to dme provider and requested to be quarantined and investigated.Patient has acknowledged her mistake and necessary oxygen safety precautions are being taken.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS, MILLENNIUM M10, OXYGEN CONCENTRATOR WITH 10L FLO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 15916203
• MDR Text Key: 304816212
• Report Number: MW5113617
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M10
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White