GIBECK IPN041364Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026704347841), received between Oct 6, 2023 and Mar 28, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Unable to Obtain Readings; Device Sensing Problem; Unable to Obtain Readings; Device Sensing Problem

  IT WAS REPORTED THAT: "HEALTHCARE CLINICIAN USED A HUMID-VENT PEDI FILTER ON A PATIENT IN THE DAY CLINIC AND WAS UNABLE TO OBTAIN A CO2 READING ON THE CAPNOGRAPH. CLINICAL CONSEQUENCES: THE FILTER WAS REPLACED AND THE DR WAS THE ABLE TO OBTAIN THE DESIRED READING. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993202 ↗
• MalfunctionMar 11, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT : "THE DEVICE WAS DISCOVERED TO HAVE A PARTIALLY BLOOKED PORT. THERE WAS NO CO2 TRACE WHEN EXPECTED, ISOLATED FAULT TO HME, NOTICED SAMPLING PORT LUMEN WAS BLOCKED." ADDITIONAL INFORMATION: THERE WAS NO HEALTH CONSEQUENCES TO THE PATIENT AND NO DESATURATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874122 ↗
• MalfunctionFeb 27, 2024Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  IT WAS REPORTED THAT " ABSENT CAPNOGRAPHY TRACE DESPITE BEING ABLE TO VENTILATE THE PATIENT. ON INSPECTION, NO OPENING BETWEEN THE CAPNOGRAPHY PORT AND THE FILTER ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786898 ↗
• InjuryOct 9, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT, "BLOCKAGE IN FILTER PREVENTING VENTILATION OF PEDIATRIC PATIENT. SEEMS TO HAVE PLASTIC INSIDE IT CAUSING BLOCKAGE. PATIENT WAS UNABLE TO BE VENTILATED. NO CARBON DIOXIDE READING WAS OBTAINED. ALL ASPECTS OF CIRCUIT WERE EXAMINED. THE FILTER WAS FOUND TO BE THE CAUSE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17897320 ↗
• MalfunctionOct 6, 2023Defective Device; Defective Device

  THE REPORT STATES THAT "THE FILTER HAS A PORTAL WHICH IS BLOCKED WITH A PIECE OF PLASTIC THUS OCCLUDING IT AND NOT ALLOWING THE PATIENT'S ANESTHESIA CIRCUIT TO WORK. IT WAS NOTICED PRIOR TO USE ON A PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887539 ↗