MAUDE Adverse Event Report: MANUFACTUER INFORMATION IS NOT AVAILABLE FROM THE VENDOR; OXYGEN E-TANK

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/21/2015

Event Type  Death  

Event Description

(b)(6) sustained second and third degree burns to his face due to oxygen explosion.Allegedly the patient was smoking while on oxygen.He was taken to (b)(6).(b)(6) was ready to be sent home on (b)(6) 2015 but expired in the hospital prior to that.Oxygen was ordered from the vendor: (b)(4).

• Brand Name: NA
• Type of Device: OXYGEN E-TANK
• Manufacturer (Section D): MANUFACTUER INFORMATION IS NOT AVAILABLE FROM THE VENDOR
• MDR Report Key: 4508564
• MDR Text Key: 18033355
• Report Number: 4508564
• Device Sequence Number: 1
• Product Code: CAW
• 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: 01/30/2015

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: Other
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/21/2015
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 67 YR