MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS OXYGEN REGULATOR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 01/18/2021

Event Type  Death  

Manufacturer Narrative

A report from staff for a customer on oxygen therapy at home saw on a news report that a fire occurred resulting in death.The last equipment known in use included an oxygen regulator item number res043.News report indicates the fire was caused by smoking in the home.No further information is available.

Event Description

A report from staff for a customer on oxygen therapy at home saw on a news report that a fire occurred resulting in death.The last equipment known in use included an oxygen regulator item number res043.News report indicates the fire was caused by smoking in the home.No further information is available.

• Brand Name: OXYGEN REGULATOR
• Type of Device: OXYGEN REGULATOR
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer (Section G): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer Contact: nazree williams ; 180 n. michigan ave; suite 2000; chicago, IL 60601 ; 3125332457
• MDR Report Key: 11555074
• MDR Text Key: 241831604
• Report Number: 3006446479-2021-00002
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death