MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER ULTRAFILL, ME36 3000PSI; GENERATOR, OXYGEN, PORTABLE

Model Number 1065718

Device Problem Gas/Air Leak (2946)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/28/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a technician received a burn from a cylinder that was leaking.The technician was adjusting the regulator and it sparked and burnt the technician.It is unknown if medical attention was required.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a technician allegedly received burns from a cylinder that was leaking.The technician was adjusting the regulator and it sparked and burnt the technician.It is unknown if medical attention was required.The manufacturer recieved information from the reporting facility that the cylinder is not returning for evaluation.

• Brand Name: CYLINDER ULTRAFILL, ME36 3000PSI
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8293578
• MDR Text Key: 134621559
• Report Number: 1040777-2019-00007
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K091191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1065718
• Device Catalogue Number: 1065718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other