HAMILTON-C6 160021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,175 adverse event reports that list this exact device (DI 07630002808590), received between Feb 8, 2022 and Sep 30, 2026 — classified as 10 deaths, 53 injuries, 1,112 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (417 reports).

5 FDA recall records name this device's identifier, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 3, 2025Open, Classified

   A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.

   Z-2328-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

2. May 15, 2024Open, Classified

   Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

   Z-2020-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

3. Mar 14, 2023Open, Classified

   Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

   Z-1429-2023 · Root cause: Software design · Recall details · FDA record ↗

4. Sep 22, 2022Open, Classified

   Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.

   Z-0267-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jun 27, 2022Open, Classified

   Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed

   Z-1525-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,175 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Customer states: On (b)(6).2026, during ventilation, the device displayed the error message ¿O¿ sensor failed¿ and stopped displaying the O¿ value. The FiO¿ was set to 30% when the message appeared. The patient¿s oxygen saturation subsequently decreased and stabilized at 91%. The FiO¿ was then increased to 100%, and the typical sound of oxygen flowing into the device during flushing was immediately heard. The device was replaced. No permanent patient harm was reported.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50942632 ↗
• MalfunctionSep 28, 2026Gas/Air Leak

  Hamilton Medical AG received the following description: Upon starting operation of the HAMILTON-C6, the device fails to reach the programmed tidal volume. The pre-operational check was repeated, and new consumables were installed; however, the issue persisted. The active humidification system was also adjusted, as excessive condensation was suspected of affecting the measurements, but this did not resolve the issue.Despite optimizing the consumable setup, repeating the pre-operational check, and adjusting the humidification, the issue remains unresolved.No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912498 ↗
• MalfunctionSep 28, 2026No Display/Image

  Hamilton Medical AG received the following description: During patient use, the HAMILTON-C6 screen went blank; however, ventilation continued. The screen subsequently recovered. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912155 ↗
• MalfunctionSep 28, 2026No Flow; Noise, Audible

  Hamilton Medical AG received the following description: It was reported that during the ventilation of a patient, blower started to do a mechanical noise. The ventilator was exchanged. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910850 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  Hamilton Medical AG received the following event description: Upon starting operation of the HAMILTON-C6, the device fails to reach the programmed tidal volume. The pre-use check procedure was optimized, and the unit was restarted with new consumables, but the issue persisted. Active humidification settings were also adjusted¿considering that excessive condensation might be interfering with measurements¿but this did not resolve the problem either. Despite optimizing the setup of consumables, the pre-use check, and humidification settings, the issue remained unresolved. The replacement and verification of the complete patient circuit were reported as the medical intervention performed.No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881637 ↗
• InjurySep 24, 2026Improper Flow or Infusion

  Hamilton Medical AG received the following description: "Suctioning was performed on the patient via the endotracheal tube. Suddenly, the patient's oxygen saturation dropped to 85%. The ventilator first issued a low minute volume warning, followed by a "patient circuit disconnected" alert. All connections were checked, but nothing was loose. The patient was not being ventilated. The flow sensor was replaced, but there was no change. A physician examined the airways using a fiberscope; mucus was found primarily within the endotracheal tube, but the airways themselves were clear. The ventilator was replaced, and the patient's condition stabilized. At the onset of the incident, the patient's EtCO2 waveform had flatlined, indicating that the patient was not actually being ventilated."No further patient consequences were reported.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50881059 ↗
• MalfunctionAug 24, 2026Intermittent Communication Failure

  Hamilton Medical AG received the following event description: It was reported that during ventilation, the screen rebooted. A medical intervention was reported; however, the only detail provided was that use of the ventilator was discontinued. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50403042 ↗
• MalfunctionJun 29, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE WAS ALARMED WITH THE FOLLOWING TECHNICAL FAULTS AND EVENT: TE 231009 ; TF1485001; TF1446029; TF431001 ; TF1746004 ; TF446029. THE DEVICE WAS REPLACED WITH ANOTHER ONE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649561 ↗
• MalfunctionJun 24, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT DURING THE VENTILATION OF A PATIENT, THE DEVICE VENTILATION STOPPED WITH THE FOLLOWING TECHNICAL EVENTS 231009 (BLOWER CONTROLLER SPEED LOW), 231032 (EXPIRATION VALVE DISCONNECTED) AND TECHNICAL FAULTS 431017 (INSPIRATION VALVE DISCONNECTED), 431002 (BLOWER DISCONNECTED). NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604782 ↗
• MalfunctionJun 11, 2026Inaccurate Flow Rate

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: FOLLOWING A SUCCESSFUL COMPLETION OF THE PREOPERATIVE CHECKS, THE VENTILATOR WAS CONNECTED TO A PATIENT. SHORTLY THEREAFTER, THE DEVICE FAILED TO DELIVER VOLUME TO THE PATIENT AND GENERATED A PATIENT SIDE DISCONNECTION ALARM. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467098 ↗
• MalfunctionJun 8, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE DISPLAYED THE MESSAGE "VENTILATION CANCELLED", AFTER WHICH THE SCREEN BECAME BLANK/BLACK. THE VENTILATOR WAS REMOVED FROM SERVICE, AND THE PATIENT WAS SUBSEQUENTLY VENTILATED MANUALLY USING A RESUSCITATION BAG. NO HARM TO THE PATIENT WAS REPORTED. DURING AN ONSITE VISIT CONDUCTED TWO DAYS AFTER THE EVENT, THE SERVICE TECHNICIAN SUCCESSFULLY RETRIEVED THE DEVICE LOG FILES. A REVIEW OF THE LOGS IDENTIFIED THE OCCURRENCE OF A MONITOR DISCONNECT ALARM AND AN EXPIRATORY VALVE DISCONNECT ALARM PRIOR TO THE DEVICE TRANSITIONING TO AMBIENT STATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423131 ↗
• DeathJun 1, 2026Insufficient Device Problem Information

  A PATIENT PASSED AWAY WHILE ON THE DEVICE. REPORTED NO ISSUES WITH THE DEVICE AND LOGS ARE NEEDED TO BE REVIEWED BY US BEFORE RELEASING THE DEVICE BACK INTO SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 25350317 ↗
• MalfunctionMay 27, 2026Display or Visual Feedback Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT DURING PATIENT VENTILATION, THE VENTILATOR ENTERED SAFETY VENTILATION AND GENERATED THE FOLLOWING TECHNICAL FAULTS: TF 346054 ¿ SAFETY VENTILATION, TF 1385002 ¿ SAFETY MODE HAPPEN, TF 1746004 ¿ PANEL ERROR VIA SEMAPHORE RECEIVED, AND TF 341908 ¿ TVMC_VENTCONTROL:VCSC::CALCSETTINGSFORBACKUPMODEE. THE VENTILATOR DISPLAY ALSO BECAME BLACK. THE VENTILATOR WAS SUBSEQUENTLY REPLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296615 ↗
• MalfunctionMay 25, 2026Display or Visual Feedback Problem

  HAMILTON MEDICAL AG RCIVED THE FOLLOWING DESCRIPTION: IT WAS REPORTED THAT THE VENTILATOR FAILED TO PROVIDE VENTILATION TO THE PATIENT. THE DEVICE GENERATED THE ALARMS ¿PANEL CONNECTION LOST¿ AND ¿VENTILATION CANCELED.¿ THE PATIENT WAS MANUALLY VENTILATED USING A MANUAL BREATHING BAG WITH CONTINUOUS ETCO2 MONITORING. THE AFFECTED VENTILATOR WAS DISCONNECTED FROM THE PATIENT AND REPLACED WITH ANOTHER VENTILATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268833 ↗
• DeathMay 12, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: A PATIENT PASSED AWAY WHILE ON VENTILATOR. NO ISSUES REPORTED WITH DEVICE. IT IS INDICATED THAT A MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, THE ACCOMPANYING COMMENT STATES: ¿PATIENT WAS REMOVED FROM DEVICE AS THE PATIENT HAD PASSED AWAY,¿ FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE REPORTED EVENT. THE CAUSALITY OF THE DEATH IN RELATION TO THE HAMILTON-G6 HAS NOT YET BEEN DETERMINED AND IS CURRENTLY UNDER INVESTIGATION. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: Insufficient Information

  MAUDE report 25146750 ↗
• MalfunctionMay 8, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE DISPLAYED A BLOWER ERROR DURING USE AND STOPPED VENTILATING. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED. LOG FILE ANALYSIS CONFIRMED A SEQUENCE OF BLOWER RELATED TECHNICAL EVENTS (TE244018, TE231009) FOLLOWED BY MULTIPLE TECHNICAL FAULTS (TF431001, TF446029, TF1446029, TF1485001, TF1746004), LEADING TO AUTOMATIC TRANSITION INTO AMBIENT STATE AND LOSS OF ACTIVE VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120863 ↗
• MalfunctionMay 7, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: IT WAS REPORTED THAT DURING THE VENTILATION OF A PATIENT, THE DEVICE DISPLAYED A BLOWER FAILURE. THE VENTILATOR WAS REPLACED. NO HARM TO THE PATIENT WAS REPORTED. LOG FILE ANALYSIS CONFIRMS THAT DURING ACTIVE VENTILATION ON (B)(6) 2026, A BLOWER VOLTAGE OUT-OF-TOLERANCE CONDITION (TE244018) AND BLOWER CONTROLLER SPEED ISSUE (TE231009) OCCURRED, FOLLOWED BY A CASCADE OF TECHNICAL FAULTS INCLUDING TF431001 (BLOWERFAULT) AND AMBIENT FAILURE DETECTIONS (TF446029 / TF1446029 / TF1485001).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108990 ↗
• MalfunctionMay 5, 2026Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: UPON ADMISSION, THE PATIENT WAS VENTILATED USING A HAMILTON C6 VENTILATOR. INITIAL BLOOD GAS ANALYSIS SHOWED A CO2 LEVEL OF 38 MMHG. APPROXIMATELY 90 MINUTES LATER, THE PATIENT¿S CO2 LEVEL ROSE TO 122 MMHG. DURING THIS TIME, CLINICAL STAFF OBSERVED AN ABNORMAL AUDIBLE NOISE COMING FROM THE EXPIRATORY VALVE (EXHALATION BLOCK) OF THE VENTILATOR. THE VENTILATOR WAS EXCHANGED WITH ANOTHER ONE. FOLLOWING THE SWAP, THE PATIENT¿S CO2 LEVELS DROPPED IMMEDIATELY TO 40 MMHG. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076709 ↗
• MalfunctionApr 15, 2026No Flow

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING VENTILATION OF A PATIENT, THE DEVICE GENERATED THE ALARM ¿BLOWER FAILURE.¿ A REVIEW OF THE EVENT LOGS SHOWS THE FOLLOWING TECHNICAL EVENTS AND TECHNICAL FAILURES: 17:36:37 ¿ TECHNICAL EVENT TE 244018: VOLTAGE OUT OF TOLERANCE 17:36:38 ¿ TECHNICAL EVENT TE 231009: BLOWER CONTROLLER SPEED LOW 17:36:48 ¿ MULTIPLE TECHNICAL FAILURES RECORDED INCLUDING: TF 431001: BLOWER FAULT TF 446029: AMBIENT STATE DETECTED. THE PATIENT WAS MANUALLY VENTILATED USING A RESUSCITATION BAG AND SUBSEQUENTLY SWITCHED TO AN ALTERNATIVE VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880837 ↗
• MalfunctionApr 14, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE WAS VENTILATING THE PATIENT WHEN IT STOPPED SUDDENLY. THE DEVICE WAS SHOWING MULTIPLE ALARMS RELATED TO THE BLOWER. THE VENTILATOR WAS REPLACED WITH ANOTHER ONE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870826 ↗
• MalfunctionApr 9, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT DURING THE VENTILATION OF A PATIENT, THE DEVICE SHOWED A NUMBER OF ALARM MESSAGES INCLUDING ¿SAFETY VENTILATION, CANCELLED VENTILATION¿ AND, THEN VENTILATOR SWITCHED OFF. THE VENTILATOR WAS SWAPPED OUT WITH ANOTHER VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829155 ↗
• MalfunctionApr 7, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE EVENT WAS REPORTED AS A TECHNICAL EVENT INVOLVING BLOWER AND MAINBOARD, WITH HIGH BLOWER TEMPERATURE READING AND AMBIENT FAILURE DURING VENTILATION. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798281 ↗
• MalfunctionApr 3, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: IT WAS REPORTED THAT THE DEVICE WOULD NOT DELIVER VOLUME / BREATH TO PATIENT. ADDITIONALLY, WOULD NOT TURN OFF. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773715 ↗
• MalfunctionMar 31, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT DURING VENTILATION, THE DEVICE STOPPED SUDDENLY. THE DEVICE ALARMED WITH TE231009.NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738769 ↗
• MalfunctionMar 30, 2026Noise, Audible

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: ACCORDING TO THE COMPLAINT DESCRIPTION THE DEVICE ALARMED WITH TE 244018. 128/2026-03-11 05:29:18/TF /446029 129/2026-03-11 05:29:18/TF /431001 130/2026-03-11 05:29:18/TF /1746004 131/2026-03-11 05:29:18/TF /1446029 132/2026-03-11 05:29:18/TF /1485001 133/2026-03-09 17:23:17/TEST /TEMPERATURE CPU IP, MAX: 53.0°C, AVG: 50.7°C TF 431001 = BLOWER FAULT TF 446029 = AMBIENT FAILURE DETECTED. THE PATIENT HAD TO BE MOVED TO A DIFFERENT VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726804 ↗