HAMILTON-C1Recalls & reported problems across all models

We found 2 models of HAMILTON-C1 by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 2,012 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2021 and Sep 30, 2026 — classified as 15 deaths, 21 injuries, 1,975 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (425 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HAMILTON-C1 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 26, 2023Class IOpen, 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 · names 2 of these models · Recall details · FDA record ↗

2. Jun 15, 2023Class IOpen, 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 · Recall details · FDA record ↗

Most reported HAMILTON-C1 problems

HAMILTON-C1 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HAMILTON-C1 161001

  Ventilator, Continuous, Facility Use
  2 recalls12 deaths1,849 reports
• HAMILTON-C1 1610010

  Ventilator, Continuous, Facility Use
  1 recall3 deaths163 reports

Recent HAMILTON-C1 adverse event reports

The 15 most recent reports across all models, 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, 2026No Audible Alarm; No Apparent Adverse Event

  Hamilton Medial AG received the following complaint description (summary):It was reported that, on (b)(6) 2026, a HAMILTON-C1 (Product No. 1610010, S/N (b)(6), SW 3.1.1) "did not audibly alarm while alarm condition existed on patient." Patient involvement was reported. No patient, user, or third-party harm and no medical intervention were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913717 ↗
• 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 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  RT was called to bedside due to nursing stating that ventilator was spontaneously shutting off. RT came to bedside and nursing stated it happened while suctioning. RT suctioned patient and all flow from the ventilator stopped completely and patient O2 saturations dropped to low 80's and required support from AMBU bag to improve saturations. RT replaced flow sensor and exhalation valve and still the machine shut off all flow after suctioning despite the patient spontaneously breathing.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50182653 ↗
• InjuryAug 7, 2026Insufficient Device Problem Information

  While switching oxygen from tank to wall, alarm appeared "No oxygen " or "oxygen supply failed ". Duplicated the event in department and noticed that it took some time for the C1 to alarm that the vent had no oxygen. Once the O2 hose was plugged back in, the vent took some time to stop alarming "no oxygen. " It seems to reset itself because the alarm disappears. Unsure if this is normal with C1's but it did result in both patients desatting. Another event happened when vent was turned on, immediately received an alarm for "oxygen supply failed ". I switched the quick connect and that seemed to fix the issue. I took that same quick connect to the department to trial it on another unit but did not receive the same issue.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50182648 ↗
• 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 ↗
• MalfunctionJul 1, 2026Improper Flow or Infusion

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE HAMILTON-C1 VENTILATOR WAS ¿NOT GIVING FULL BREATHS¿ DURING PATIENT VENTILATION, ONLY 50¿60 ML AIR DELIVERED, NO LEAK FOUND, AND "HIGH RESPIRATORY RATE" ALARM WAS TRIGGERED. NO PATIENT, USER OR THIRD PARTY HARM NOR MEDICAL INTERVENTION WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676704 ↗
• 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 21, 2026Application Program Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE SHUTDOWN DURING VENTILATION AND ALARMED WITH TF 385002 (SAFETY FAILURE DETECTED), TF 485001 (AMBIENT FAILURE DETECTED), TF 443001 (WATCHDOG FAILED LLS). NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240038 ↗

Other Hamilton Medical AG products

• HAMILTON-G52 models · 1,891 reports
• HAMILTON-T15 models · 1,185 reports · 3 recalls
• HAMILTON-C22 models · 853 reports · 1 recall
• HAMILTON-MR12 models · 151 reports · 2 recalls
• Breathing circuit set, coaxial4 models · 24 reports · 2 recalls