HAMILTON-G5 159001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,440 adverse event reports that list this exact device (DI 07630002800013), received between Jan 21, 2021 and Sep 30, 2026 — classified as 18 deaths, 27 injuries, 1,395 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (278 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,440 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Flow

  Hamilton Medical AG received the following event description: TF 5509 and TF 9907 occured during ventilation. Also there is "Power fail" recorded in the logs. Medical intervention was reported, ventilator was replaced. It was reported that the event did not lead to any serious injury or adverse health effects for any patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945196 ↗
• MalfunctionSep 30, 2026Infusion or Flow Problem

  Hamilton Medical AG received the following event description: "TF 5509. Inspiration valve fault. Problem occured during ventilation, resulting in ambient mode." Medical intervention was reported, ventilator was replaced. It was reported that the event did not lead to any serious injury or adverse health effects for any patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942911 ↗
• MalfunctionJun 30, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DURING INSPECTION, WE FOUND THAT A SELF-TEST FAILED ALARM WAS DISPLAYED ON THE MACHINE. WE SUSPECTED AN ISSUE WITH THE SERVO MODULE. TO CONFIRM THE FAULT, WE CROSS-CHECKED BY INSTALLING A NEW SERVO MODULE, AND THE MACHINE OPERATED NORMALLY. THEREFORE, THE FAULTY SERVO MODULE WAS REPLACED WITH A NEW ONE. ALL TESTS AND CALIBRATIONS WERE COMPLETED SUCCESSFULLY AFTER THE REPLACEMENT. THE MACHINE WAS HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION." NO PATIENT INVOLVEMENT WAS REPORTED. NO HARM, SERIOUS INJURY OR ADVERSE HEALTH CONSEQUENCES TO ANY PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664229 ↗
• DeathJun 25, 2026Insufficient Device Problem Information

  SEE A FACEBOOK VIDEO OF A HAMILTON G5 THAT IS SEVERLY BURNED, SEE ALSO A VENTILAIR MAYBE EVEN AN H900, NOT SURE. SEVERELY BURNED. VIDEO STATES ALLEGED DEATH: HTTPS://WWW.FACEBOOK.COM/THENURSEERICA/VIDEOS/4488099788184556/ LINK TO VIDEO.

  Patient problems: Insufficient Information

  MAUDE report 25629411 ↗
• InjuryJun 24, 2026Mechanical Jam

  COMPLAINT REPORTED TO HMI CLINICAL APPLICATION SPECIALIST: DURING INTERHOSPITAL TRANSPORT OF A PATIENT THE USER REPORTED A "NO OXYGEN" FAILURE WHEN CONNECTED TO O2 TANK. THE PATIENT BEGAN TO DESATURATE SO THE USER SWITCHED THE O2 TANK. ONCE IN THE ROOM THE USER REMOVED THE VENTILATOR AND SWITCHED TO ANOTHER HAMILTON-G5. REPORTED VENTILATOR SETTINGS WERE: "100% 02, PEEP +16, VT 430, RR 28, 5L FLOW TRIGGER." (DESCRIPTION OF EVENTS PROVIDED BY RT MANAGER AT FACILITY, NOT PRESENT DURING THE EVENT. DIRECT REPORT FROM USER NOT AVAILABLE AT THIS TIME.)

  Patient problems: Low Oxygen Saturation

  MAUDE report 25615934 ↗
• MalfunctionApr 23, 2026Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "TF: 9907 & 5509 ALARM, AND THE UNIT CANNOT USE." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964644 ↗
• MalfunctionMar 10, 2026Loose or Intermittent Connection

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE USER TRIED TO TURN ON THE DEVICE AND THE ERROR MESSAGE ¿PANEL CONNECTION LOST¿ APPEARED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559274 ↗
• MalfunctionMar 9, 2026False Positive Result

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT ON 19.02.2026 THEY HAVE SEEN A RANDOM ERROR TF5507. AFTER THIS, DURING TEST USE WITH TEST LUNG, THE FAULT TF5507 APPEARED WITH INCREASED FREQUENCY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543068 ↗
• MalfunctionMar 5, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "I FOUND ALARM TF 5509,9907 WHEN TURN ON UNIT." 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 24517438 ↗
• MalfunctionMar 3, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "I FOUND ALARM TF 5509,9907 WHEN TURN ON UNIT." 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 24495470 ↗
• MalfunctionJan 29, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT TF9950 HAD BEEN DISPLAYED. NO HEALTH CONSEQUENCES OR IMPACT. BASED ON THE LOG FILE ANALYSIS, NO OCCURRENCE OF TF9950 WAS RECORDED. HOWEVER, THE FOLLOWING TECHNICAL FAULTS WERE IDENTIFIED IN THE DEVICE LOGS: TF9907, TF2414, AND TF5509.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206948 ↗
• MalfunctionJan 13, 2026Erratic or Intermittent Display

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH PANEL CONNECTION LOST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052247 ↗
• MalfunctionJan 9, 2026Intermittent Communication Failure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF'S 9907, 9421 DURING VENTILATION. THE VENTILATOR WAS REPLACED. NO HARM TO THE PATIENT WAS REPORTED. ACCORDING TO THE LOG FILE ANALYSIS, A PANEL CONNECTION LOST ALARM WAS RECORDED PRIOR TO THE TECHNICAL FAULTS (TF'S) MENTIONED BY THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017078 ↗
• MalfunctionJan 5, 2026Communication or Transmission Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "THE UNIT SHOWING TF:5502" NO PATIENT INVOLVEMENT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954923 ↗
• MalfunctionDec 9, 2025False Positive Result; False Positive Result

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF5507 AND AIR & OXYGEN SUPPLY FAILED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755087 ↗
• MalfunctionDec 8, 2025Pressure Problem; Pressure Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH "EXHALATION OBSTRUCTED". NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741018 ↗
• MalfunctionDec 5, 2025False Positive Result; False Positive Result

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE ALARMED WITH DISCONNECTION ON VENTILATOR SIDE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725434 ↗
• MalfunctionDec 4, 2025Medical Gas Supply Problem; Medical Gas Supply Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING VENTILATION, THE DEVICE ALARMED WITH AIR SUPPLY FAILED AND COULD NOT BE CLEARED. PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER ONE - NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714581 ↗
• MalfunctionDec 3, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: AFTER STARTUP, THE VENTILATION STARTS WITH AN AUDIBLE HIGH-PRIORITY SOUND AND A VISUAL ALARM WITH THE TF9907. IN STANDBY MODE, NO PRE-OPERATIONAL CHECK IS AVAILABLE. IN CALIBRATION MODE, NO FLOW IS DELIVERED DURING THE INSPIRATORY VALVE CALIBRATION. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702440 ↗
• InjuryNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PERSONNEL DESCRIBE THE HAMILTON G5 AS NOT MEETING ISO (B)(6) STANDARDS AND THIS CAUSING CONFUSION/EXTRA TRAINING REQUIRED FOR PERSONNEL.

  Patient problems: Insufficient Information

  MAUDE report 23650975 ↗
• InjuryNov 24, 2025Unexpected Shutdown; Unexpected Shutdown

  HARM TO THE PATIENT INCLUDED CHANGES IN VITAL SIGNS- DESATURATION AND INCREASED WORK OF BREATHING. PATIENT CONTINUED TO HAVE OXYGENATION ISSUES SHORTLY AFTER SWITCHING VENTS WITH FIO2 INCREASING FROM 30 TO 60 PERCENT. THE ATTENDING PHYSICIAN WAS NOTIFIED AND ORDERED AN ARTERIAL BLOOD GAS AND CHEST X RAY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23631504 ↗
• MalfunctionOct 29, 2025Pressure Problem; Pressure Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF 5505, 5502. THE PATIENT WAS SWITCHED TO ALTERNATIVE VENTILATOR NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412387 ↗
• MalfunctionOct 28, 2025No Flow; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: AFTER STARTUP, THE DEVICE GENERATED AN AUDIBLE HIGH-PRIORITY SOUND AND A VISUAL ALARM WITH THE TF9907. IN CALIBRATION MODE, NO FLOW IS DELIVERED DURING THE INSPIRATORY VALVE CALIBRATION. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401941 ↗
• MalfunctionOct 22, 2025Disconnection; Disconnection

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "IN DER ANWENDUNG FUNKTIONIERTEN DIE VORABCHECKS. AM PATIENTEN ZEIGTE DAS GERÄT DEN FEHLER "DISKONNEKTION RESPIRATORSEITE", OBWOHL ES KEINE DISKONNEKTION GAB. WÄHREND DER FEHLERSUCHE HATTE DAS GERÄT BEIM DICHTIGKEITSTEST UND BEI DER FLOWSENSORKALIBRIERUNG PROBLEME, DEN "ENTFERNTEN PATIENTEN" - DAS OFFENE Y-STÜCK ZU ERKENNEN. IM TEST 6 DES SERVICEMENÜS WAR EIN GLEICHLAUF VON PPAT, PAW UND PAUX BEI 0 MBAR UND BEI 80 MBAR ZU SEHEN. IM TEST 13 DES SERVICEMENÜS LIEFEN PAW UND PPAT ZU VERSCHIEDEN BEI 0 MBAR WAR PAW PLAUSIBEL BEI CA. 0 MBAR UND PPAT BEI < -3 MBAR. DER PIN DES EXSPIRATIONSVENTILS LIEF NICHT MEHR SCHÖN GLEICHMÄSSIG, NUN IST ER FEST UND BEWEGT SICH NICHT MEHR." TRANSLATED TO ENGLISH: "THE PRELIMINARY CHECKS WORKED IN THE APPLICATION. THE DEVICE DISPLAYED THE ERROR ¿DISCONNECTION ON VENTILATOR SIDE¿ ON THE PATIENT, EVEN THOUGH THERE WAS NO DISCONNECTION. DURING TROUBLESHOOTING, THE DEVICE HAD PROBLEMS RECOGNIZING THE ¿REMOTE PATIENT¿ ¿ THE OPEN Y-PIECE ¿ DURING THE LEAK TEST AND FLOW SENSOR CALIBRATION. IN TEST 6 OF THE SERVICE MENU, PPAT, PAW, AND PAUX WERE SYNCHRONIZED AT 0 MBAR AND 80 MBAR. IN TEST 13 OF THE SER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355386 ↗
• MalfunctionSep 10, 2025Calibration Problem; Calibration Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE VENTILATOR ALARMED WITH TF5510 AND 5511 DURING STANDBY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012916 ↗