HAMILTON-C3 160005Recalls & reported problems

Summary

The FDA's MAUDE database contains 587 adverse event reports that list this exact device (DI 07630002801881), received between Jan 21, 2021 and Sep 24, 2026 — classified as 1 death, 4 injuries, 582 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (124 reports).

1 FDA recall record name this device's identifier, 1 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. 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-2142-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 587 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Loss of Power

  Hamilton Medical AG received the following event description: Biomed states that the device shows loss of external power. Says it happens intermittingly. Tried different power cord and different outlet. Issue remains. Biomed opened device to look for possible loose connections, none found. - No health consequences or impact - No intervention necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877479 ↗
• MalfunctionSep 1, 2026Failure to Deliver

  Hamilton Medical AG received the following event description: on (b)(6)2026 customer reported that during ventilation once the nebulizer activated it is not working. As another option they have used stand alone Aerogen nebulizer to treat the patient. All other function of ventilators are working properly. Ventilator never stopped working, only nebulizer is not working. - No health consequences or impact - A stand-alone Aerogen nebulizer was used to continue the patient's nebulizer treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539331 ↗
• MalfunctionApr 16, 2026Tidal Volume Fluctuations

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO THE HAMILTON-C3 (UNDER SEDATION, ANALGESIA, AND INTUBATION). NO PATIENT HARM WAS REPORTED, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER DEVICE. THE PATIENT HAD BEEN CONNECTED TO A HAMILTON-C3 DEVICE, WHICH COULD NOT BE IMPROVED DESPITE REPEATED TROUBLESHOOTING. THIS RESULTED IN A RAPID RESPIRATORY RATE, POOR OXYGENATION MAINTENANCE, AND A WORSENING OF THE PATIENT¿S CONDITION. AFTER REPLACING THE VENTILATOR, THE TIDAL VOLUME RETURNED TO NORMAL, AND ECG MONITORING INDICATED IMPROVED OXYGENATION AND RESPIRATORY PARAMETERS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24895361 ↗
• MalfunctionApr 9, 2026No Flow

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT A HAMILTON-C3 VENTILATOR GENERATED TECHNICAL ALERTS TECHNICAL EVENT (TE) 231009 (BLOWER SPEED LOW) AND TECHNICAL FAULT (TF) 431002 (BLOWER DISCONNECT) DURING VENTILATION. ACCORDING TO THE USER, THE VENTILATOR ALARMED REPEATEDLY, AND THE CLINICAL TEAM SWITCHED TO A DIFFERENT VENTILATOR. A PATIENT WAS INVOLVED, AND NO PATIENT HARM NOR IMMEDIATE MEDICAL INTERVENTION WAS REPORTED. THE INFORMATION RECEIVED INCLUDES THE STATEMENT THAT THE VENTILATOR ¿STOPPED WORKING,¿ BUT THIS COULD NOT BE VERIFIED, AS NO LOG FILES WERE AVAILABLE FOR ANALYSIS AND THE REPORTED ALERTS DO NOT INHERENTLY INDICATE AN IMMEDIATE INTERRUPTION OF VENTILATION. DUE TO THE INCONSISTENT INFORMATION AND THE ABSENCE OF OBJECTIVE DATA TO CONFIRM OR EXCLUDE A THERAPY-INTERRUPTING MALFUNCTION, THE EVENT IS SUBMITTED AS A CONSERVATIVELY PREVENTIVE REPORTABLE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825475 ↗
• MalfunctionApr 2, 2026Power Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE DEVICE UNEXPECTEDLY SHUT DOWN AND TRIGGERED TF444001 (BATTERIES TOTAL DISCHARGE / BATTERY TOTALLY DISCHARGED), AFTER WHICH IT SWITCHED INTO AMBIENT MODE CONDITION. THE PATIENT WAS DISCONNECTED FROM THE HAMILTON-C3, AND THE USER PROVIDED MANUAL VENTILATION. THE DEVICE WAS THEN RESTARTED SUCCESSFULLY AND POWERED ON NORMALLY, ALLOWING VENTILATION TO BE RESUMED. THE DEVICE WAS LATER INSPECTED AND FOUND TO BE OPERATING NORMALLY. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765557 ↗
• MalfunctionMar 18, 2026Inaccurate Delivery

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: LOW OXYGEN ALARM APPEARED FREQUENTLY ON THE HAMILTON-C3 DEVICE WHILE USED WITH 100% OXYGEN. THE REPORT STATED THAT NO HEALTH CONSEQUENCES OCCURRED, AND NO CLINICAL IMPACT WAS OBSERVED. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625148 ↗
• MalfunctionJan 28, 2026Complete Loss of Power

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT INDICATING THAT THE BATTERY WAS NOT CHARGING WHILE CONNECTED TO THE MAINS POWER SUPPLY, WHICH LED TO INTERMITTENT SHUTDOWNS OF THE UNIT. THE EVENT OCCURRED WITHOUT PATIENT INVOLVEMENT. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198758 ↗
• MalfunctionDec 13, 2025No Flow; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT SUMMARY: AN AMBIENT STATE CONDITION (VENTILATOR STOPPED VENTILATING) OCCURRED WITH A HAMILTON-C3 DURING ACTIVE PATIENT VENTILATION. AN ADDITIONAL HAMILTON-C3 WAS REQUIRED TO CONTINUE THERAPY. THE PATIENT DIED WHILE ON THE ADDITIONAL HAMILTON-C3, WHICH DID NOT MALFUNCTION. ACCORDING TO HOSPITAL STAFF, THE DEATH IS NOT CONSIDERED RELATED TO THE INITIAL HAMILTON-C3 DEVICE WHERE THE AMBIENT STATE CONDITION OCCURRED. INVESTIGATION ON THE REPORTED AMBIENT MODE CONDITION FOR THE FIRST HAMILTON-C3 IN USE IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Respiratory Arrest

  MAUDE report 23797459 ↗
• MalfunctionDec 9, 2025Gas Output Problem; Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: OXYGEN SUPPLY FAILED DURING TESTING ON TEST LUNG OF VENTILATOR. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756021 ↗
• MalfunctionSep 2, 2025No Flow; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): ON (B)(6) 2025 AT 15:57:14, THE DEVICE TRIGGERED A TECHNICAL EVENT (TE) 231032 ALARM DURING ACTIVE VENTILATION AND SWITCHED TO AMBIENT MODE. PRIOR TO THIS, A HIGH MINUTE VOLUME ALARM HAD BEEN OBSERVED. THE ISSUE WAS REPRODUCIBLE (MEANS WAS RE-CONSTRUCTIBLE) : PRESSING THE START VENTILATION BUTTON CONSISTENTLY LED TO THE SAME TE ALARM AND AMBIENT MODE ACTIVATION. THE EVENT OCCURRED TWO DAYS AFTER A BLOWER MODULE REPLACEMENT. DURING INSPECTION, EXPIRATORY VALVE CALIBRATION WAS PERFORMED VIA SERVICE SOFTWARE (ADJ/CALIB AND PNEUMATIC 1), AND BOTH TESTS PASSED SUCCESSFULLY. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. NO HARM WAS REPORTED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936502 ↗
• MalfunctionSep 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): TECHNICAL FAULT (TF) 431017 (INSPIRATION VALVED IS CONNECTED) OCCURRED DURING ACTIVE PATIENT VENTILATION. AN ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931692 ↗
• MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): SELF-TEST FAILED. TECHNICAL FAULT (TF) 431017 (INSPIRATION VALVE DISCONNECTED), DEFECTIVE INSPIRATORY VALVE. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893253 ↗
• MalfunctionAug 26, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): THE COMPLAINT WAS RECEIVED WITH THE DESCRIPTION: SELF-TEST FAILED WITH TF 431008 (Q VENTFLOW SENSOR ERROR TECHNICAL FAULT), (TECHNICAL EVENT - (TE) 231012 (Q VENTFLOW SENSOR DEFECT TECHNICAL EVENT). NO PATIENT WAS INVOLVED AND NO HARM WAS REPORTED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892689 ↗
• MalfunctionAug 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (QUOTATION OF THE REPORTER): "END USER OF THE DEVICE STATES THAT DURING VENTILATION, WITHOUT WARNING, DEVICE WENT INTO SAFETY VENTILATION. DEVICE HAD TO SWITCHED OUT FOR ANOTHER." NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793414 ↗
• MalfunctionJul 25, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINANT, THE VENTILATOR FAILED THE SELF-TEST DURING STARTUP AND DISPLAYED MULTIPLE TECHNICAL FAULTS, INCLUDING TECHNICAL FAULT (TF) 431001 (BLOWER FAULT). THERE WAS NO PATIENT INVOLVEMENT REPORTED AS THE ISSUE WAS AT THE START UP. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607285 ↗
• MalfunctionJul 25, 2025Obstruction of Flow; Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): "DEVICE WENT IN AMBIENT MODE DURING VENTILATION. AFTER COMPLETING MY CHECKS I FOUND THE PLUNGER ON THE EXPIRATORY VALVE WAS STICKING.". NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606779 ↗
• MalfunctionJul 14, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): ON (B)(6) 2025, A VENTILATOR SHOWED AN AIR LEAK DURING USE ON AN ELDERLY PATIENT AND COULD NOT BE USED AS INTENDED. THE DEVICE WAS PROMPTLY REPLACED TO CONTINUE TREATMENT WITHOUT DELAY. TECHNICAL INSPECTION INDICATED A POSSIBLE RUPTURE OF THE INTERNAL EXPIRATORY MEMBRANE AS THE CAUSE OF THE LEAK. SPARE PARTS WERE ORDERED FROM THE MANUFACTURER, AND THE DEVICE WAS RESTORED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492221 ↗
• MalfunctionJul 11, 2025Loss of Data; Loss of Data

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): THE OPTIONS DISAPPEARED / OPTIONS NOT FOUND. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477327 ↗
• MalfunctionJul 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): IT WAS REPORTED THAT THE VENTILATOR SUDDENLY SHUT DOWN ("GOES BLACK") WHILE A PATIENT WAS CONNECTED. VENTILATION STOPPED UNEXPECTEDLY, AND CLINICAL STAFF HAD TO MANUALLY INTERVENE WITH A BREATHING BAG AND REPLACE THE VENTILATOR. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410210 ↗
• MalfunctionJun 5, 2025Decrease in Pressure; Decrease in Pressure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): DURING ACTIVE VENTILATION, THE DEVICE TRIGGERED A TECHNICAL EVENT TE231009 (BLOWER CONTROLLER SPEED LOW) ALARM. APPROXIMATELY 10 MINUTES LATER, IT ENTERED AMBIENT MODE TECHNICAL FAULT (TF446029), REQUIRING VENTILATOR REPLACEMENT. NO FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147829 ↗
• MalfunctionMay 1, 2025Complete Loss of Power; Complete Loss of Power

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "HAMILTON C3 SN (B)(6) 'TURNED OFF WHILE IN USE". NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941005 ↗
• MalfunctionApr 29, 2025Failure to Deliver; Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, WHEN THE RESPIRATORY TECHNOLOGIST WAS SUCTIONING, THE SCREEN WHEN BLANK AND VENTILATION STOPPED. NO HARM TO THE PATIENT WAS REPORTED. THE PATIENT WAS BAGGED UNTIL A REPLACEMENT VENTILATOR WAS USED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924770 ↗
• MalfunctionApr 4, 2025Inadequate User Interface; Inadequate User Interface

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "ON (B)(6) 2025, DURING THE OPERATION OF THE VENTILATOR, THE SCREEN AND KNOB MALFUNCTIONED, MAKING IT IMPOSSIBLE TO ADJUST THE VENTILATOR PARAMETERS. THE DEPARTMENT IMMEDIATELY STOPPED USING IT AND REPORTED IT TO THE MEDICAL EQUIPMENT DEPARTMENT FOR REPAIR, REPLACING IT WITH A SIMILAR PRODUCT TO CONTINUE TREATMENT." NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771194 ↗
• MalfunctionApr 4, 2025Loss of Data; Loss of Data

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "PROBLEM NOTIFY = OPTIONS NOT FOUND ALREADY SETTING DATE AND TIME AND RESTART." NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771027 ↗
• MalfunctionMar 26, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "THE POWER BUTTON IS NOT WORKING." NO PATIENT INVOLVED, REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695588 ↗