Mini CGA 870 style regulator; 0-15 lpm RES043Recalls & reported problems
Sunset Healthcare Solutions, Inc. · Mini CGA 870 style regulator; 0-15 lpm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848530060671), received between Jan 21, 2021 and May 31, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Partial thickness (Second Degree) Burn2
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
SUNSET HEALTHCARE SOLUTIONS RECEIVED AN FDA MEDWATCH REPORT THAT A VITAS HEALTHCARE PATIENT WAS SMOKING IN THE PRESENCE OF HER PORTABLE OXYGEN TANK WHEN IT CAUGHT FIRE. IT WAS STATED THAT THE OXYGEN TANK WAS ON AND CAUGHT FIRE, RESULTING IN 2ND AND 3RD DEGREE BURNS TO HER FACE, HANDS, AND SHOULDERS. SHE WAS TRANSPORTED BY HELICOPTER TO A BURN UNIT FOR MEDICAL ATTENTION.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 25344242 ↗InjuryJan 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
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.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 11210423 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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