GIBECK IPN043782Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04026704348664), received between Nov 1, 2021 and Apr 2, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT: "THE PATIENT WAS INTUBATED, AND THE ANESTHESIOLOGIST NOTICED A LEAK. HE FINALLY FOUND THAT THE LEAK WAS COMING FROM THE FILTER. THE FILTER WAS CRACKED. WE REMOVED THE FILTER AND REPLACED WITH A NEW ONE AND NO FURTHER PROBLEMS WERE ENCOUNTERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750823 ↗
• MalfunctionMar 25, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DURING USE IN PATIENT, IMMEDIATELY UPON REPLACING THE FILTER, WATER CONDENSATION IS OBSERVED, AND ACTIVATION OF ALARMS IN VENTILATOR DUE TO LOW SUPPLIED VOLUME, THIS WAS CORRECTED WHEN THE FILTER WAS CHANGED FOR ANOTHER". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905309 ↗
• InjuryNov 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DECREASED TIDAL VOLUME WITH USE OF THE HME. THERAPY WAS DELAYED/INTERRUPTED, AND MEDICAL INTERVENTION WAS NECESSARY. PATIENT DESATTED < 88%. THE HME HAD TO BE CHANGED OUT TO A DIFFERENT KIND". PATIENT CONDITION REPORTED AS "STABLE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12733617 ↗
• InjuryNov 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DECREASED TIDAL VOLUME WITH USE OF THE HME. THERAPY WAS DELAYED/INTERRUPTED, AND MEDICAL INTERVENTION WAS NECESSARY. PATIENT DESATTED (B)(4). THE HME HAD TO BE CHANGED OUT TO A DIFFERENT KIND". PATIENT CONDITION REPORTED AS "STABLE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12733600 ↗
• InjuryNov 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DECREASED TIDAL VOLUME WITH USE OF THE HME. THERAPY WAS DELAYED/INTERRUPTED, AND MEDICAL INTERVENTION WAS NECESSARY. PATIENT DESATTED < 88%. THE HME HAD TO BE CHANGED OUT TO A DIFFERENT KIND". PATIENT CONDITION REPORTED AS "STABLE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12733577 ↗
• InjuryNov 1, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DECREASED TIDAL VOLUME WITH USE OF THE HME. THERAPY WAS DELAYED/INTERRUPTED, AND MEDICAL INTERVENTION WAS NECESSARY. PATIENT DESATTED < 88%. THE HME HAD TO BE CHANGED OUT TO A DIFFERENT KIND". PATIENT CONDITION REPORTED AS "STABLE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12733519 ↗