HAMILTON-C2 160001Recalls & reported problems

Summary

The FDA's MAUDE database contains 807 adverse event reports that list this exact device (DI 07630002800372), received between Aug 22, 2022 and Sep 18, 2025 — classified as 15 injuries, 792 malfunctions.

The most frequently reported specific device problem is “Defective Component” (190 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-2141-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 807 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Insufficient Cooling; Insufficient Cooling

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): THE DEVICE ALARMED WITH ¿FAN FAILURE¿ DURING AND AFTER STARTUP. THE ISSUE WAS IDENTIFIED DURING A NON-CLINICAL PROCEDURE USING A TEST LUNG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081856 ↗
• MalfunctionJul 22, 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): "VENTILATOR SHOWING BLOWER SERVICE REQUIRED AND SELF TEST FAILED." 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 22563284 ↗
• MalfunctionMay 23, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY OF THE CUSTOMER/REPORTER): WHITE & BLUE SCREEN DURING VENTILATION WITH ERROR CODE. NO PATIENT WAS HARMED, THE BEHAVIOR CAN BE REPLICATED. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076758 ↗
• MalfunctionMar 19, 2025Circuit Failure; Circuit Failure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "WHILE DEVICE WAS ON STANDBY WE GET AUDIBLE/VISIBLE ALARM AND TF 485001, TF 446029, TF 446022, TF 446030 AT RANDOM TIMES. STARTUP PROCEDURE IS OK AND DEVICE PASSES SERVICE TESTS BUT WHILE DOING THE TESTS I DID GET SAME TF CODES ONCE WHILE DOING O2 CALIBRATION AND ONCE WHEN DEVICE WAS IN SERVICE MODE "MAIN SCREEN". LOGS." HEALTH IMPACT: NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642231 ↗
• MalfunctionMar 4, 2025Decrease in Pressure; Decrease in Pressure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "VENTILATOR SHOWS TECHNICAL FAULT TECHNICAL FAULT (TF) 431002 (BLOWER DISCONNECTED) ON STARTUP." NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513227 ↗
• MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "TECHNICAL EVENT (TE (B)(4): BLOWER CONTROLLER SPEED LOW) DURING VENTILATION AND LATER SELF TEST FAILED AT STARTUP." HEALTH IMPACT: ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466652 ↗
• MalfunctionFeb 25, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "VENTILATOR SHOWS TECHNICAL FAULT TECHNICAL FAULT (TF) 431002 (BLOWER DISCONNECT) ON STARTUP." HEALTH IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WERE REPORTED. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456753 ↗
• MalfunctionFeb 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): DISPLAY FLICKERING DURING START UP. HEALTH IMPACT: NONE. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS REPORTED. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456306 ↗
• MalfunctionFeb 18, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): THE COMPLAINT HAS BEEN RECEIVED AS " AMBIENT TEST FAILED, AFTER THE AMBIENT VALVE EXCHANGE, THE DEVICE WORKS WITHOUT ANY FAILURE." THE AMBIENT VALVE TEST FAILED IN SERVICE SOFTWARE. HEALTH IMPACT: NONE, NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395097 ↗
• MalfunctionFeb 13, 2025Decrease in Pressure; Decrease in Pressure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "- TE 231009 (ALARM BLOWER SPEED LOW) - BLOWER FLOW TEST FAILED - BLOWER PRESSURE TEST FAILED - BLOWER MODULE ASSEMBLY REPLACED." NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372453 ↗
• MalfunctionFeb 10, 2025Power Problem; Power Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): LOSS OF EXTERNAL POWER, AC POWER NOT INDICATING, POWER SUPPLY BOARD REPLACED. HEALTH IMPACT: NONE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342884 ↗
• MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "RELEASE VALVE DEFECTIVE/TIGHTNESS TEST FAILS." HEALTH IMPACT: NONE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342665 ↗
• MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING: (1) COMPLAINT DESCRIPTION (QUATATION FROM THE CUSTOMER/REPORTER): "AFTER STARTUP DEVICE GIVES 231007 (O2 CONTROLLER FLOW HIGH) AND 231008 (O2 VALVE LEAK) TECHNICAL EVENT. CAN HEAR THAT HPO O2 IS LEAKING SOMEWHERE. FROM SERVICE MENU - SENSOR DATA - FLOW SENSOR QO2 IS SHOWING ~17L/MIN EVEN WHEN FLOW IS SET TO 0." (2) HEALTH IMPACT: NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341559 ↗
• MalfunctionFeb 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER): "DISPLAY BLANK AND SOMETIMES FLICKERING DISPLAY." NO PATIENT INVOLVEMENT DURING MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321529 ↗
• MalfunctionFeb 5, 2025Decrease in Pressure; Decrease in Pressure

  COMPLAINT DESCRIPTION QUOTATION OF THE CUSTOMER/REPORTER: "TECHNICAL EVENT: 231009 ("BLOWER CONTROLLER SPEED LOW"), BLOWER TEST FAILED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311492 ↗
• MalfunctionFeb 4, 2025Inaccurate Flow Rate; Incorrect Measurement; Inaccurate Flow Rate; Incorrect Measurement

  (1) COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER): "ALARM - EXTERNAL FLOW SENSOR FAILED. FLOW SENSOR CALIBRATION FAILED." (2) HEALTH IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND ADDITIONAL DEVICE REQUIRED, WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301341 ↗
• MalfunctionJan 17, 2025Decrease in Pressure; Decrease in Pressure

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DEVICE ALARMS WITH HIGH PRIORITY TECHNICAL EVENT: 231009 (ALARM BLOWER SPEED LOW) DUE TO DEFECTIVE BLOWER. (2) HEALTH IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177098 ↗
• MalfunctionJan 17, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DURING START UP OCCURED THE TECHNICAL FAULT 444004 (VOLTAGE OUT OF TOLERANCE) AND SELFTEST FAILED. (2) HEALTH IMPACT: NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177043 ↗
• MalfunctionJan 17, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "FUNCTION KEYS ARE NOT WORKING". (2) HEALTH IMPACT: NO HEALTH CONSEQUENCES OR IMPACT AND NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176992 ↗
• MalfunctionJan 10, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DEVICE IS NOT BOOTING UP.". NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124931 ↗
• MalfunctionJan 10, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DEVICE IS NOT BOOTING UP." NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124856 ↗
• MalfunctionJan 10, 2025Decreased Pump Speed; Improper Flow or Infusion; Decreased Pump Speed; Improper Flow or Infusion

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "BLOWER FLOW TEST FAILED." (2) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123864 ↗
• MalfunctionJan 8, 2025Use of Device Problem; Inaccurate Delivery; Use of Device Problem; Inaccurate Delivery

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION SUMMARY: "BLOWER DEFECTIVE ALARMS ALONG WITH NOT PERFORMED MAINTENANCE ISSUE." (2) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100769 ↗
• MalfunctionJan 7, 2025Failure of Device to Self-Test; Activation Failure; Failure of Device to Self-Test; Activation Failure

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "SELF TEST FAILED." (2) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089372 ↗
• MalfunctionJan 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DISPLAY NOT COMING (FULL WHITE DISPLAY)." (2) NO PATIENT INVOLVEMENT. FOUND PROBLEM DURING GENERAL MAINTENANCE VISIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078941 ↗