GIBECK IPN043768Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04026704348022), received between May 7, 2021 and Feb 20, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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.

• InjuryFeb 20, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT "WE HAD A BACTERIAL FILTER FAIL ON ONE OF OUR ANESTHETIC MACHINES CAUSING THE PATIENT TO DESATURATE AND DRUGS WERE GIVEN TO THE PATIENT TO NO EFFECT. ON FURTHER INVESTIGATION IT WAS DISCOVERED THAT PART OF THE PAPER FILTER WAS MOVING WITH THE PATIENT RESPIRATIONS. THE FILTER WAS NOT WET. THERE MAY ALSO HAVE BEEN A LEAK AT THE BOTTOM OF THE CO2 SAMPLING PORT. ONCE THE FILTER WAS REPLACED THE PATIENT'S SATS' RETURNED TO NORMAL LEVELS AND THE OPERATION WAS COMPLETED WITHOUT FURTHER ISSUES". THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21423458 ↗
• MalfunctionMay 11, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: Capsular Contracture

  MAUDE report 16913347 ↗
• MalfunctionMay 11, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913299 ↗
• MalfunctionMay 11, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913179 ↗
• MalfunctionMay 11, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. THIS CAUSES A BREAK IN THE BREATHING CIRCUIT AND CUTS OFF THE DELIVERY OF OXYGEN TO A PATIENT WHO IS CONTINUOUSLY VENTILATOR DEPENDENT. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. THERE WAS NO PATIENT HARM, INJURY, OR DESATURATION AS THE ISSUE WAS DISCOVERED PRIOR TO USE WHEN ASSEMBLING THE TUBING. AS A RESULT, AN "ALTERNATIVE" FILTER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913003 ↗
• MalfunctionApr 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "WATER LEAKING IN THE HME FILTER WHILE ATTACHED TO THE VENTILATOR AND PATIENT. OCCURED DURING VENTILATION TREATMENT. THE FILTER WAS REPLACED." AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16765572 ↗
• MalfunctionMay 7, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT "DURING THE PRE-TEST, ALERT LEAKAGE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794508 ↗
• MalfunctionMay 7, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DURING THE PRE-TEST, ALERT LEAKAGE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794353 ↗