MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS OXYGEN REGULATOR CGA 870 STYLE BARBED OUTLET 0-15 LPM

Model Number	RES043
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End user reports on (b)(6) 2020 the end user was changing out an oxygen tank and when placing the regulator on the tank a hissing sound was heard.End user reports second degree burns on ring finger, index finger and on the thumb.End user went to the emergency room for treatment.
Event or Problem Description
End user reports changing out an oxygen tank and when the end user placed the regulatory (res043) onto the oxygen tank, there was a hissiing noise heard.End user then reports second and third degree burns on the thumb, index finger and ring finger.End user reports going to the emergency room for treatment.
Additional Manufacturer Narrative
End user reports on december 21, 2020 the end user was changing out an oxygen tank and when placing the regulator on the tank a hissing sound was heard.End user reports second degree burns on ring finger, index finger and on the thumb.End user went to the emergency room for treatment.Supplemental report 2.19.2021: the customer filing the initial incident performed an evaluation of the device through their processes and informed sunset healthcare solutions on january 28, 2021 that the device was working properly and demonstrated no issues.The device has not yet been returned to sunset healthcare solutions.
Event or Problem Description
End user reports changing out an oxygen tak and when the end user placed the regulatory (res043) onto the oxygen tank, there was a hissiing noise heard.End user then reports second and third degree burns on the thumb, index finger and ring finger.End user reports going to the emergency room for treatment.

• Brand Name: OXYGEN REGULATOR CGA 870 STYLE BARBED OUTLET 0-15 LPM
• Common Device Name: OXYGEN REGULATOR
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago 60601
• MDR Report Key: 11210423
• Report Number: 3006446479-2021-00001
• Device Sequence Number: 3928107
• Product Code: CAN
• UDI-Device Identifier: 00848530060671
• UDI-Public: 00848530060671
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: RES043
• Device Catalogue Number: RES043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention