SuperNO2VA SSM-20 (UDI 10889483166307)Recalls & reported problems
Airlife · SuperNO2VA Nasal PAP Ventilation System, Medium · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483166307), received between May 23, 2025 and May 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT; REFER TO 1314417-2025-00033 FOR THE SECOND REPORT; REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081878 ↗MalfunctionMay 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT. REFER TO 1314417-2025-00033 FOR THE SECOND REPORT. REFER TO 1314417-2025-00034 FOR THE THIRD REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081876 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.