OXYGEN REGULATOR CGA 870 STYLE BARBED OUTLET 0-15 LPM
Received Jan 21, 2021 · Event occurred Dec 21, 2020
Report 3006446479-2021-00001 · MDR key 11210423
Device
Generic name
Oxygen Regulator
Manufacturer
Sunset Healthcare SolutionsModel number
RES043Catalog number
RES043
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
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.
Description of Event or Problem
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.
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.
Description of Event or Problem
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.