MAUDE Adverse Event Report: SUNSET; OXYGEN SUPPLY TUBING

Device Problem No Apparent Adverse Event (3189)

Patient Problem Fall (1848)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned.(b)(4).

Event Description

Please see user facility report number (b)(4).

• Brand Name: SUNSET
• Type of Device: OXYGEN SUPPLY TUBING
• Manufacturer Contact: 180 n. michigan ave; suite 2000; chicago, IL 60601
• MDR Report Key: 8384114
• MDR Text Key: 137661055
• Report Number: 3006446479-2019-00005
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening