HAMILTON-C1 161001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,849 adverse event reports that list this exact device (DI 07630002800747), received between Jan 21, 2021 and Sep 30, 2026 — classified as 12 deaths, 15 injuries, 1,821 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (408 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jul 26, 2023Open, Classified

   Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

   Z-2525-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Jun 15, 2023Open, Classified

   Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

   Z-2139-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,849 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure

  Hamilton Medical AG received the following event description (Summary): It was reported that, during an inspection on 21 August 2026, the self-test of a HAMILTON-C1 ventilator, S/N (b)(6) failed and technical faults (TF) 431002 and 444004 were displayed. No patient, user, or third party was involved. No harm or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945757 ↗
• MalfunctionSep 28, 2026Circuit Failure

  Hamilton Medial AG received the following complaint description (summary): It was reported that a HAMILTON-C1 (Product No. 161001, S/N (b)(6), software version not reported) spontaneously entered repeated reboot cycles without user interaction on 28-Aug-2026. No patient involvement, harm of user or third-party, or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912837 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Hamilton Medical AG received the following event description (Quotation): "- During inspection, we found that the machine¿s self-test was failing.- We cross-checked the machine with a new control board, after which the machine started working properly and the self-test was completed successfully.- This confirmed that the existing control board was defective.- We replaced the defective control board with a new one. The machine is now working properly, and all tests and calibration procedures were successfully completed.- The machine was handed over to the customer in good working condition. "No patient involvement, harm, or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910849 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Hamilton Medial AG received the following complaint description (summary):It was reported that a HAMILTON-C1 (Product No. 161001, S/N: (b)(6), SW 3.0.3) experienced Technical Fault (TF) TF785003 (PM Channel Observation Failed). Log review identified repeated occurrences of TF785003 together with TF444004 (Voltage Out of Tolerance), TF446029 (Ambient Failure Detected), and TF485001 (Ambient Failure Detected). No patient involvement, harm, or medical intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895478 ↗
• MalfunctionSep 7, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649445 ↗
• DeathJul 21, 2026Restricted Flow rate

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT IMMEDIATELY AFTER THE START OF VENTILATION OF THE HAMILTON-C1, ALARMS INCLUDING "DISCONNECTION ON PATIENT SIDE," "MAXIMUM LEAK COMPENSATION," "VT LOW," AND "LOW MINUTE VOLUME" OCCURRED REPEATEDLY. AT APPROXIMATELY 12:00, VENTILATION WAS SWITCHED TO MANUAL VENTILATION; HOWEVER, THE PATIENT SUBSEQUENTLY DIED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 25886065 ↗
• DeathJul 20, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT WHILE THE HAMILTON-C1 WAS BEING USED ON A PATIENT, IT SUDDENLY SWITCHED TO AMBIENT MODE. THE VENTILATOR WAS REPLACED; HOWEVER, THE PATIENT SUBSEQUENTLY DIED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 25871418 ↗
• MalfunctionJul 6, 2026Operating System Becomes Nonfunctional

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: PER THE CUSTOMER, 'KEYS LOCKED ON VENT WHILE ON A PATIENT. STAFF UNABLE TO MAKE ANY CHANGES DUE TO SCREEN BEING LOCKED, AFTER FEW HOURS ON STANDBY IT WENT TO AMBIENT MODE AND COULDN'T DO ANYTHING. BATTERY WAS FULL, AC WAS PLUGGED' ISSUE WAS REPORTED BY THE CUSTOMER AFTER EVENT DATE. - NO HEALTH CONSEQUENCES OR IMPACT - REPLACED WITH A DIFFERENT C1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713502 ↗
• MalfunctionJun 3, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE VENTILATOR REPEATEDLY GENERATED AN "EXHALATION OBSTRUCTED" ALARM DURING VENTILATION. THE LOCAL SERVICE ENGINEER STARTED TROUBLESHOOTING BY ADJUSTING VENTILATOR PARAMETERS AND REPLACING THE EXPIRATORY VALVE SET. HOWEVER, THE ISSUE PERSISTED. THE DEVICE SUBSEQUENTLY PASSED ALL SERVICE SOFTWARE TESTS, AND THE ALARM COULD NOT BE REPRODUCED USING A TEST LUNG. THE SAME ALARM RECURRED WHEN THE VENTILATOR WAS CONNECTED TO THE PATIENT ON (B)(6) 2026. AS A RESULT, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR, WITH THE SAME SETTINGS AND VENTILATION CONTINUED WITHOUT FURTHER ISSUES. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371200 ↗
• MalfunctionMay 21, 2026Failure to Charge

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: UNIT IS NOT WORKING WITH MAINS. NO CHARGING INDICATION. - NO PATIENT INVOLVEMENT - NO INTERVENTION NECESSARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241277 ↗
• MalfunctionMay 11, 2026Incorrect Measurement

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE REPORT FROM HOSPITAL SAY: WHEN THE OXYGEN CONCENTRATION IS SET ABOVE 80% DURING USE, THE OXYGEN CONCENTRATION DETECTION ERROR IS LARGE, AND THE MACHINE WILL ALARM FOR LOW OXYGEN CONCENTRATION AND EMIT A LOUD NOISE - NO HEALTH CONSEQUENCES OR IMPACT - THE STANDBY MACHINE WAS IMMEDIATELY REPLACED. ADDITIONAL INFORMATION RECEIVED ON 1TH MAY 2026: THE REPORT FROM HAMILTON MEDICAL TECHNOLOGIES IN CHINA WAS RECEIVED WHICH PROVIDED NEW INFORMATION ABOUT THE CASE. THE FOLLOWING WAS DESCRIBED: "WHEN THE OXYGEN CONCENTRATION WAS SET ABOVE 80% DURING USE, THERE WAS A LARGE ERROR IN OXYGEN CONCENTRATION DETECTION, AND THE MACHINE ISSUED A LOW OXYGEN CONCENTRATION ALARM AND A ROARING SOUND". THE STANDBY MACHINE WAS IMMEDIATELY REPLACED AND THE MEDICAL EQUIPMENT DEPARTMENT WAS NOTIFIED FOR REPAIR. THE MEDICAL EQUIPMENT DEPARTMENT CONTACTED THE MANUFACTURER'S ENGINEER, AND THE DEVICE RETURNED TO NORMAL AFTER SOFTWARE REINSTALLATION. NO INJURY WAS CAUSED AS THE PROBLEM WAS DETECTED AND THE STANDBY MACHINE WAS REPLACED IMMEDIATELY DURING USE. THE FAILURE MAY BE CAUSED BY A MALFUNCTION AT THE OXYGEN INHALATION VALVE, RESULTING IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133950 ↗
• MalfunctionMay 5, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING TRANSPORT, THE VENTILATOR INITIALLY FUNCTIONED NORMALLY BUT SUBSEQUENTLY SHUT DOWN, DISPLAYING A WHITE SCREEN AND ALARM (TF 432001, 446029, 485001). THE DEVICE DID NOT DELIVER VOLUME OR VENTILATE UNTIL IT WAS POWERED OFF AND RESTARTED. NO HARM TO THE PATIENT WAS REPORTED ADDITIONALLY, IT WAS MENTIONED THAT THE USER REPORTED THE EVENT TO THE LOCAL AUTHORITIES. THE REFERENCE NUMBER PROVIDED IS REF#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078972 ↗
• MalfunctionApr 20, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT ON (B)(6) 2026 THE HAMILTON-C1 VENTILATOR WITH SN (B)(6) SWITCHED FROM VOLUME CONTROL MODE TO PRESSURE CONTROL MODE-SET RATE NOT BEING DELIVERED, ALARMS NOT WHERE THEY WERE PREVIOUSLY SET. PATIENT INVOLVEMENT WAS REPORTED. HOWEVER, NO MEDICAL INTERVENTION AND NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925350 ↗
• MalfunctionApr 1, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "NO DELIVERY OF GASES DURING HIGH FLOW O2 THERAPY. MEASURED GAS DELIVERY DISPLAYED ON SCREEN READS BETWEEN 0.0 LPM AND 0.3LPM. DEVICE DOES NOT ALARM OR INDICATE THAT THERE IS ISSUE WITH GAS DELIVERY." - NO HEALTH CONSEQUENCES OR IMPACT. NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755625 ↗
• MalfunctionApr 1, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "HOSPITAL STAFF SAYS DEVICE CHANGED MODES ON ITS OWN WITH NO INPUT FROM STAFF." NO ADDITIONAL INFORMATION WAS PROVIDED. NO HEALTH CONSEQUENCES OR IMPACT. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753170 ↗
• MalfunctionMar 30, 2026Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT "AT 00:30 ON (B)(6) 2026, THE PATIENT'S VENTILATOR SUDDENLY BECAME NON VENTILATED AND THE MONITOR TRIGGERED A LOW OXYGEN ALARM." THE VENTILATOR WAS EXCHANGED. FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725855 ↗
• MalfunctionMar 19, 2026Complete Loss of Power

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING INSPECTION, IT WAS FOUND THAT THE MACHINE WAS NOT SWITCHING ON. UPON CHECKING, NO INDICATION OF AC SUPPLY WAS OBSERVED. FURTHER INSPECTION REVEALED THAT THE POWER SUPPLY BOARD WAS BURNED. NO PATIENT WAS INVOLVED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638342 ↗
• MalfunctionMar 9, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE ALARMED WITH EXHALATION OBSTRUCTION ALARMS DURING VENTILATION OF A PATIENT. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544560 ↗
• MalfunctionMar 3, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE VENTILATOR IS NOT CHARGING. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494676 ↗
• MalfunctionFeb 27, 2026Electrical Shorting

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE HAMILTON-C1 WITH SN (B)(6) WAS IN STANDBY (NO PATIENT INVOLVEMENT AT THAT TIME) AND SUDDENLY, A NURSE OBSERVED A BURNING SMELL IN THE ROOM WHERE THE DEVICE WAS PLACED. IT IS REPORTED THAT SPARKS WERE OBSERVED ON THE PLUG (NOT IN THE DEVICE ITSELF), FOLLOWED BY OPEN FLAMES AND BLACK SMOKE. THE FLAMES QUICKLY EXTINGUISHED, AND THE PLUG NATURALLY FELL OFF, WITH THE METAL PART REMAINING IN THE CEILING-MOUNTED SOCKET. THE DEVICE WAS IMMEDIATELY SEGREGATED. THE ELECTRICIAN USED TOOLS TO PULL OUT THE METAL PART FROM THE CEILING-MOUNTED SOCKET. NO PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. THERE WAS NO REPORT THAT THE EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY TO ANY INDIVIDUAL, INCLUDING HEALTHCARE PERSONNEL. REVIEW OF THE DEVICE HISTORY INDICATES THAT PREVENTIVE MAINTENANCE AND PERIODIC ELECTRICAL SAFETY TESTING HAD NOT BEEN PERFORMED IN ACCORDANCE WITH THE SERVICE MANUAL FOR SEVERAL YEARS PRIOR TO THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS THEREFORE ATTRIBUTED TO USE ERROR RELATED TO FAILURE TO PERFORM REQUIRED MAINTENANCE AS SPECIFIED BY THE MANUFACTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466322 ↗
• MalfunctionFeb 11, 2026Gas/Air Leak; Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "RT EXPERIENCING EXHALATION OBSTRUCTION ALARMS IN NEONATAL MODE WHEN THEY BELIEVE THERE SHOULD BE NONE. SECOND OCCURANCE. INSTRUCTING STAFF TO REPLACE EXHALATION VALVE REGARDLESS OF FINDINGS. " IT WAS MENTIONED THAT PATIENT WAS INVOLVED. BUT NO HEALTH CONSEQUENCES OR IMPACT AND NO INTERVENTION NECESSARY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314264 ↗
• MalfunctionFeb 6, 2026Tidal Volume Fluctuations

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DEVICE NOT DELIVERING BREATH AND REACHING PRESSURE CAP." NO HEALTH CONSEQUENCES OR IMPACT. NO INTERVENTION NECESSARY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276317 ↗
• MalfunctionJan 12, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "ATTENDED THE BREAKDOWN CALL. DURING INSPECTION, IT WAS FOUND THAT THE MACHINE HAD AN OXYGEN SUPPLY FAILURE, AND A HIGH OXYGEN ALARM WAS DISPLAYED. THE NEW O2 MIXER ASSEMBLY WAS CROSS-CHECKED, AND THE ISSUE WAS RESOLVED. THE MIXER ASSEMBLY WAS REPLACED WITH A NEW, AFTER WHICH THE MACHINE WAS FOUND TO BE WORKING PROPERLY. THE MACHINE WAS HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION." - NO PATIENT INVOLVEMENT - NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033865 ↗
• MalfunctionJan 8, 2026Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "HOSPITAL STAFF SAYS THAT WHILE VENTILATING THE PATIENT, THE DEVICE SWITCHED TO STANDBY MODE WITHOUT INTERACTION FROM STAFF. PLEASE SEE COMPLAINT FORM." NO HEALTH CONSEQUENCES OR IMPACT. PATIENT REMOVED FROM DEVICE AND PLACED ON ANOTHER. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR, NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000941 ↗
• MalfunctionJan 7, 2026Excess Flow or Over-Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "WHILE VENTILATING A PATIENT IN SPONT MODE, THE DEVICE BEGAN TRIGGERING >100 BREATHS/MIN WHEN APNEA BACKUP KICKED IN. HAD TO PROVIDE ALTERNATE MEANS OF VENTILATION, APPEARS THAT FLOW TRIGGER WAS ATTEMPTED TO INCREASE TO AVOID IT TRIGGERING." THERE WAS NO REPORT OF HARM TO PATIENT, USER OR THIRD PARTY, NOR A TREATMENT IN DELAY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987449 ↗