DAR 350/5879Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884522041888), received between Aug 5, 2021 and Jan 13, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT REPEATED AIR LEAKS FROM ANESTHESIA FILTER WAS DETECTED DURING USE IN THE HOSPITAL, WHICH COMPROMISED THE INTEGRITY OF THE FILTERS AND CAUSED INTERMITTENT SELF-TEST FAILURES ON ANESTHESIA MACHINES. THE CASE COULD NOT START, AS THE ANESTHESIA MACHINE WAS NOT PASSING THE SELF TEST PHASE. SO, EVERYTIME THE FILTER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063329 ↗
• MalfunctionJan 8, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT REPEATED AIR LEAKS FROM ANESTHESIA FILTER WAS DETECTED DURING USE IN THE HOSPITAL, WHICH COMPROMISED THE INTEGRITY OF THE FILTERS AND CAUSED INTERMITTENT SELF-TEST FAILURES ON ANESTHESIA MACHINES. THE CASE COULD NOT START, AS THE ANESTHESIA MACHINE WAS NOT PASSING THE SELF TEST PHASE. SO, EVERY TIME THE FILTER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016381 ↗
• MalfunctionJan 8, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT REPEATED AIR LEAKS FROM ANESTHESIA FILTER WAS DETECTED DURING USE IN THE HOSPITAL, WHICH COMPROMISED THE INTEGRITY OF THE FILTERS AND CAUSED INTERMITTENT SELF-TEST FAILURES ON ANESTHESIA MACHINES. THE CASE COULD NOT START, AS THE ANESTHESIA MACHINE WAS NOT PASSING THE SELF TEST PHASE. SO, EVERYTIME THE FILTER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016357 ↗
• MalfunctionJan 8, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT REPEATED AIR LEAKS FROM ANESTHESIA FILTER WAS DETECTED DURING USE IN THE HOSPITAL, WHICH COMPROMISED THE INTEGRITY OF THE FILTERS AND CAUSED INTERMITTENT SELF-TEST FAILURES ON ANESTHESIA MACHINES. THE CASE COULD NOT START, AS THE ANESTHESIA MACHINE WAS NOT PASSING THE SELF TEST PHASE. SO, EVERYTIME THE FILTER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016351 ↗
• MalfunctionJan 8, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT REPEATED AIR LEAKS FROM ANESTHESIA FILTER WAS DETECTED DURING USE IN THE HOSPITAL, WHICH COMPROMISED THE INTEGRITY OF THE FILTERS AND CAUSED INTERMITTENT SELF-TEST FAILURES ON ANESTHESIA MACHINES. THE CASE COULD NOT START, AS THE ANESTHESIA MACHINE WAS NOT PASSING THE SELF TEST PHASE. SO, EVERYTIME THE FILTER HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016347 ↗
• MalfunctionMay 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE FILTER FAILED A LEAK TEST AT A HOSPITAL. THERE WAS NO OBVIOUS SURFACE DAMAGE NOTED, BUT THE ITEM DID NOT PASS THE LEAKAGE TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073065 ↗
• MalfunctionFeb 22, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE BREATHING SYSTEM FILTER CRACKED OPEN DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760074 ↗
• DeathAug 5, 2021Filtration Problem; Filtration Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD UNSPECIFIED FILTER MALFUNCTION. THE PATIENT DIED FROM PNEUMONIA IN THE RIGHT UPPER LOBE WITH SEVERE RESPIRATORY ACIDOSIS AS WELL AS ACUTE RENAL FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 12283226 ↗