HAMILTON-G5 159002Recalls & reported problems
Hamilton Medical AG · 5900 · Class 2
Quick summary
This Hamilton-G5 ventilator is a breathing machine used in hospitals. Many of its 451 reports describe false readings, calibration failures, gas or air leaks, and no flow, and some describe alarms that could not be seen. The reports list 3 deaths, 5 injuries and 443 malfunctions, and no recalls name this device. Reports fell to 45 in the most recent year from 117 in the year before.
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
- 451
- Deaths reported
- 3
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 07630002802208), received between Jul 21, 2022 and Sep 30, 2026 — classified as 3 deaths, 5 injuries, 443 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (82 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
- False Positive Result82
- Failure to Calibrate49
- No Flow43
- Gas/Air Leak41
- Alarm Not Visible36
- Gas Output Problem33
- Circuit Failure27
- Electrical /Electronic Property Problem13
Patient problems
- No Clinical Signs, Symptoms or Conditions439
- Insufficient Information9
- Low Oxygen Saturation6
- Bradycardia2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Asystole1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 451 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Intermittent Continuity
Hamilton Medical AG received the following event description: "TF 9905, 9906, 9907 PERSISTING EVEN WHEN IN TEST MODE."No patient involvement. The event did not lead to any serios injury or adverse health effects to any patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942698 ↗MalfunctionJun 5, 2026Gas/Air Leak
IT WAS REPORTED TO HAMILTON MEDICAL AG THE TECHNICAL EVENT ERROR 8912 - PUMP RUNS AND HAS PRESSURE BUT NEVER SHUTS OFF AND DOES NOT REACH TARGET PRESSURE OF 25, PUMP IS LEAKING. AT THE TIME OF THE EVENT, THE PATIENT WAS CONNECTED TO THE VENTILATOR. NO INTERVENTION WAS DEEMED NECESSARY, AND NO INJURY OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25406572 ↗MalfunctionMay 27, 2026Infusion or Flow Problem
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING VENTILATION, THE DEVICE WAS AUTO-CYCLING AND ALARMED WITH DISCONNECTION ON VENTILATOR SIDE. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298989 ↗MalfunctionMay 19, 2026Failure to Calibrate
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "TF 5507 HAPPENED AFTER CALIBRATION ATTEMPTED TO CALIBRATE THE PRESSURE AT 0 AND FULL SCALE. TRIED CALIBRATING THE DP MIXER VALVE" IT WAS REPORTED NO HEALTH CONSEQUENCES OR IMPACT TO ANY PATIENT. NO INTERVENTION NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215985 ↗MalfunctionApr 23, 2026Failure to Calibrate
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "INSPIRATORY VALVE MALFUNCTION. FAILED DURING STARTUP. TF5509 AND TF9907. OCCURS EVERY TIME VENT IS POWERED ON" NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24964394 ↗MalfunctionApr 7, 2026Pressure Problem
IT WAS REPORTED TO HAMILTON MEDICAL AG: "REPORTED TF 9612 WHEN CO2 CABLE IS CONNECTED. NO PATIENT HARM, DISCOVERED DURING PM. INITIATING WPO FOR REPLACEMENT MOTHERBOARD." NO PATIENT WAS INVOLVED. EVENT OCCURRED DURING THE PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799188 ↗MalfunctionApr 6, 2026False Positive Result
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE HAMILTON-G5 VENTILATOR DISPLAYED THE TECHNICAL FAULT: "TF 5507". PATIENT WAS INVOLVED. NO INTERVENTION NECESSARILY, NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789293 ↗MalfunctionApr 2, 2026Failure to Recalibrate; Failure to Calibrate
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: ¿TF 5510 TF 5511 AFTER CALIBRATING FLOW SENSOR SEVERAL TIMES. MANUAL SAYS TO REPLACE SENSOR BOARD¿ NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764463 ↗MalfunctionMar 30, 2026Deflation Problem
IT WAS REPORTED TO HAMILTON MEDICAL AG: ¿FAULT 8912¿ PATIENT WAS INVOLVED. NO INTERVENTION NECESSARILY, NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729664 ↗MalfunctionMar 30, 2026Failure to Calibrate
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: ¿VENT BEGAN AUTO-TRIGGERING ON PATIENT AND THERE WAS SUBSTANTIAL PATIENT VOLUME LOSS. PATIENT BAGGED WHILE FLOW SENSOR, FILTERS, AND DISPOSABLE EXHALATION VALVE CHANGED. WHEN THE ATTEMPT WAS MADE TO PRE-USE CHECK THE VENT AFTER THE FLOW SENSOR CHANGE, WE WERE UNABLE TO PERFORM A LEAK TEST OR A FLOW SENSOR CALIBRATION TEST. THE VENT WOULD NOT CYCLE THROUGH THE TESTS AS IF IT WERE FROZEN. SWITCHED OUT VENTILATOR, PATIENT ISSUE RESOLVED AND NOW STABLE ON NEW VENTILATOR.¿ A PATIENT WAS INVOLVED AND MEDICAL INTERVENTION (MANUAL VENTILATION) WAS REQUIRED. HOWEVER, NO ADVERSE HEALTH CONSEQUENCES OR INJURIES TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727931 ↗MalfunctionMar 24, 2026Failure to Calibrate
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION RELATED HAMILTON-G5 VENTILATOR: ¿MALFUNCTIONED WHILE ON PATIENT, AUTO-TRIGGERING BREATHS & WILL NOT PASS TESTING.¿ PATIENT WAS INVOLVED. HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADVERSE HEALTH EFFECTS OR CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680539 ↗MalfunctionMar 19, 2026Smoking
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE HAMILTON-G5 VENTILATOR: ¿WHEN I PLUGGED IT IN THE BOARD WHERE THE POWER CORD PLUGS INTO STARTED SMOKING¿. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT. NO INTERVENTION WAS REQUIRED, AND NO HEALTH EFFECTS OR CONSEQUENCES TO ANY PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637684 ↗MalfunctionMar 18, 2026False Positive Result
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT ¿TF: 5507 AND TF 5512 APPEARED DURING VENTILATION.¿ PATIENT WAS INVOLVED. NO INTERVENTION NECESSARILY, NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626680 ↗MalfunctionMar 13, 2026Circuit Failure
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT DURING VENTILATION, DEVICE DISPLAYED PANEL CONNECTION LOST ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND SUPPORTED BY ALTERNATIVE MEANS. NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597105 ↗MalfunctionMar 13, 2026Circuit Failure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "PANEL CONNECTION LOST. TF:9914/9950 APPEARED." PATIENT WAS INVOLVED. NO INTERVENTION NECESSARILY, NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24588776 ↗MalfunctionFeb 25, 2026Loose or Intermittent Connection
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "CONTROL PANEL LOST AND INVALID SERIAL NUMBER". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442972 ↗MalfunctionFeb 16, 2026Failure to Calibrate
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE VENTILATOR HAMILTON-G5 IS EXPERIENCING TECHNICAL FAULTS (TF) 5510 AND 5511. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342700 ↗MalfunctionFeb 6, 2026Improper Flow or Infusion
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE GENERATED TF5510 AND TF5511 THE PATIENT HAD TO BE TAKEN OFF THE VENTILATOR AND VENTILATED WITH AMBU. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276048 ↗MalfunctionFeb 4, 2026Deflation Problem; Inflation Problem
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF 8912. NO HEATH CONSEQUENCE OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24255840 ↗MalfunctionFeb 3, 2026False Positive Result
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE ALARMED WITH DISCONNECTION ON PATIENT SIDE MESSAGES. NO HEATH CONSEQUENCE OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244574 ↗MalfunctionFeb 2, 2026False Positive Result
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT DURING PM THE DEVICE ALARMS WITH DISCONNECTION ON PATIENT SIDE AND AUTOCYCLES. NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231768 ↗MalfunctionJan 28, 2026Intermittent Communication Failure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE SHOWED TF 9950. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197908 ↗MalfunctionJan 28, 2026Circuit Failure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE GENERATED TF 5500 TF5505. NO PATIENT INVOLVEMENT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197736 ↗MalfunctionJan 28, 2026Circuit Failure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING VENTILATION, THE DEVICE GENERATED TF 5510 AND 5511. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197415 ↗MalfunctionJan 26, 2026No Flow
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE GENERATED TF5509 , TF9907 AND TF2414 - NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176579 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.