HAMILTON-C2 160002Recalls & reported problems
Hamilton Medical AG · Class 2
Quick summary
This Hamilton C2 ventilator is a portable breathing machine used in hospitals and during emergency rescues. The 46 reports mostly describe the unit failing to power up or failing its self-check, air or gas leaks, and loose connections; in several cases staff had to switch patients to a manual breathing bag. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 07630002800730), received between Oct 4, 2023 and Dec 8, 2025 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (9 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up9
- Gas/Air Leak5
- Insufficient Device Problem Information5
- Failure of Device to Self-Test4
- Circuit Failure3
- Loose or Intermittent Connection3
- Decrease in Pressure2
- Defective Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information3
- Low Oxygen Saturation1
- Respiratory Failure1
- Respiratory Insufficiency1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Disconnection; Disconnection
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): DURING AN EMERGENCY RESCUE, THE HAMILTON-C2 VENTILATOR FAILED AND COULD NOT BE USED AS INTENDED. MEDICAL STAFF IMMEDIATELY SWITCHED TO A MANUAL RESUSCITATION BAG TO PROVIDE VENTILATION, WHICH CAUSED A BRIEF DELAY IN INITIATING RESPIRATORY SUPPORT. 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 23741937 ↗MalfunctionJan 10, 2025Circuit Failure; Circuit Failure
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "THE REPORT FROM HOSPITAL SAY: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION AND HEART FAILURE. DURING THE PROCESS OF ASSISTED BREATHING WITH A VENTILATOR, THE MOTOR MALFUNCTIONED, WHICH MAY HAVE CAUSED A POWER FAILURE IN THE SYSTEM DUE TO PROLONGED OPERATION OF THE VENTILATOR, RESULTING IN THE VENTILATOR BEING UNABLE TO FUNCTION PROPERLY AND ENDANGERING THE PATIENT'S LIFE. OTHER INVASIVE VENTILATORS WERE IMMEDIATELY ADJUSTED FOR THE PATIENT'S USE. AFTER EXAMINATION, IT WAS FOUND THAT THE FAN BLADES WERE STUCK AND THE COIL WAS BURNED, CAUSING THE COMPRESSOR TO OVERHEAT AND PROTECT. THE PATIENT RETURNED TO THE FACTORY TO REPLACE THE COOLING FAN AND ELIMINATE THE FAULT." (2) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21123495 ↗MalfunctionJan 6, 2025Failure to Calibrate; Insufficient Device Problem Information; Failure to Calibrate; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "THE REPORT FROM HOSPITAL SAY: THE PATIENT WAS GIVEN A HAMILTON C2 VENTILATOR ON (B)(6) 2024 DUE TO HEART FAILURE. SELF CHECK OF THE VENTILATOR BEFORE USE FAILED. THE NURSE IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH ANOTHER VENTILATOR TO TREAT THE PATIENT." (2) INSUFFICIENT INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21078503 ↗MalfunctionOct 28, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: VENTILATOR SHUTOFF ON PATIENT AND TURNED BACK ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543262 ↗MalfunctionOct 25, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: UNIT DOESN'T START UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531180 ↗MalfunctionOct 25, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: "CHECK HARDWARE COMPATIBILITY" IS SHOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531035 ↗MalfunctionAug 7, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: UNIT IS LONGER TRANSMITTING DATA TO THE CAPSULE. NOTICED THE RS 232 CONNECTION BOARD ON THE C2 IS LOOSE/NO LONGER MAKING FULL CONTACT TO THE CONTROL BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19926218 ↗MalfunctionJul 10, 2024Gas Output Problem; Medical Gas Supply Problem; Gas Output Problem; Medical Gas Supply Problem
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: OXYGEN SUPPLY FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19709294 ↗MalfunctionJul 1, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: FLOW SENSOR CALIBRATION FAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641661 ↗MalfunctionJun 27, 2024Infusion or Flow Problem; Infusion or Flow Problem
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: THE CUSTOMER INFORMED ME THAT DURING ITS LAST USE, THE UNIT ALARMED WITH "LOW OXYGEN". DURING THE PM CHECKS, THE UNIT IS FAILING THE O2 MIXER CHECKS. AT 21% O2, IT IS READING 27. AT 61 AND 90 IT IS WITHIN SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19622013 ↗MalfunctionJun 14, 2024Premature Discharge of Battery; Failure to Power Up; Premature Discharge of Battery; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: UNIT DOESN'T START UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19535475 ↗MalfunctionMay 28, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LOSS OF EXTERNAL POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19403493 ↗MalfunctionMay 23, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: UNIT DOESN'T START UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19378964 ↗MalfunctionMay 21, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: AFTER REPLACING CRACKED SCREEN. TESTED EVERYTHING. PROBLEM WITH KNOB. YOU CAN OPERATE IT BUT IT ONLY SELECTS 2 OPTIONS OR WHEN YOU TURN THE KNOW IT MOVES 1 STEP FORWARD AND 1 STEP BACK IT CAN'T GO FURTHER .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356896 ↗MalfunctionApr 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE REPORT FROM HOSPITAL SAY: FREQUENT ALARM OF REVERSAL OF FLOW SENSOR, NORMAL DIRECTION OF FLOW SENSOR CONNECTION. NO HEALTH CONSEQUENCES OR IMPACT. UNKNOWN IF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19018907 ↗MalfunctionMar 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: BLANK DISPLAY DUE TO DEFECTIVE ESM BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18990074 ↗MalfunctionMar 6, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF431002 BLOWER DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18845817 ↗MalfunctionFeb 15, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: HOSPITAL STAFF STATES THAT DURING VENTILATION THE DEVICE JUST SWITCHED MODES. BIOMED DOES NOT KNOW WHAT THEY WERE DOING OR MODE THEY WERE IN. SAYS SOME OF THE STAFF ARE NEW. PATIENT WAS REMOVED FROM THE VENT AND PLACED ON ANOTHER. DEVICE HAS BEEN PULLED FROM SERVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18708872 ↗MalfunctionFeb 2, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LOSS OF EXTERNAL POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629749 ↗MalfunctionJan 25, 2024Failure to Recalibrate; Failure to Recalibrate
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: O2 CELL DEFECTIVE ALARMS / O2 CALIBRATION FAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18578117 ↗MalfunctionJan 25, 2024Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: UNIT DOESN'T START UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18578066 ↗MalfunctionJan 8, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: WHITE DISPLAY SCREEN AFTER START-UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18462701 ↗MalfunctionDec 21, 2023Device Alarm System; Device Alarm System
THE REPORT FROM HOSPITAL SAY: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON JUL. 10 AND DIAGNOSED WITH SEVERE PNEUMONIA AND RESPIRATORY FAILURE. AFTER ADMISSION, THE PATIENT WAS GIVEN A C2 VENTILATOR FOR NON-INVASIVE MECHANICAL VENTILATION. AT 05:00 ON JUL. 11, IMMEDIATELY AFTER THE BLOOD OXYGEN SATURATION DROPPED TO 89%, THE PATIENT WAS SUBJECT TO OROTRACHEAL INTUBATION, AND THE VENTILATOR MODE WAS SIMV; THE VENTILATOR DID NOT ALARM AT NIGHT, AND THE PATIENT'S BLOOD OXYGEN SATURATION ROSE TO 92%-98%. AT 10:00 IN THE MORNING, THE DOCTOR CHANGED THE VENTILATOR MODE TO PCV. AFTER THAT, THE VENTILATOR'S ALARM PERSISTED: THE TIDAL VOLUME WAS LOW, AND THE VENTILATOR LINE FELL OFF HAMILTON-C2 MADE IN 2012
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18376656 ↗MalfunctionDec 21, 2023Misassembly by Users; Misassembly by Users
THE REPORT FROM HOSPITAL SAY: ON (B)(6) 2022, IN THE 107 WARD AREA, BUILDING 1, THE MEDICAL STAFF TURNED ON THE VENTILATOR BUT FOUND THAT THE MACHINE COULD NOT WORK. AFTER STARTUP, THE FLOW SENSOR SHOWED AN ALARM "FLOW SENSOR REVERSE". HAMILTON-C2 MADE IN MAR. 9, 2018
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18372182 ↗MalfunctionDec 21, 2023Failure to Power Up; Failure to Power Up
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: OPTIONS DISAPPEARED AFTER REPLACE THE ESM BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18370618 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.