MAUDE Adverse Event Report:; OXYGEN CONCENTRATOR

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Respiratory Distress (2045); Partial thickness (Second Degree) Burn (2694)

Event Date 07/23/2017

Event Type  Injury  

Event Description

On (b)(6)2017, the pt's caregiver was sleeping and was awakened by pt screaming.The caregiver found the pt with flames on her face, chest and arms.He was able to put out the flames but the pt was noted with burns on her face and arms.The pt refused for the caregiver to call 911 or vitas.The following day ((b)(6)2017), the pt began to have respiratory distress and the caregiver called 911.The pt was seen by evac staff, who felt the pt needed to be airlifted to (b)(6) for treatment.After the pt was airlifted, the caregiver called vitas to notify.While at the hospital it was identified that the pt had sustained second degree burns to her face and arms.She was treated and discharged the same day.Unable to identify mfr and (b)(4) specific after multiple attempts of contacting (b)(4) company.The pt and caregiver were instructed not to smoke with the oxygen on, they were instructed not to smoke in the vicinity of the oxygen concentrator.The pt and caregiver verbalized understanding of the dangers while smoking with the oxygen on, or near them.The caregiver agreed to take responsibility for the proper use of the equipment, and ensure that the pt did not smoke with the oxygen on.

• Brand Name: UNK
• Type of Device: OXYGEN CONCENTRATOR
• MDR Report Key: 6785276
• MDR Text Key: 82443904
• Report Number: 6785276
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2017

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2017
• Distributor Facility Aware Date: 07/24/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 54