HAMILTON-T1 161006Recalls & reported problems

Summary

The FDA's MAUDE database contains 471 adverse event reports that list this exact device (DI 07630002801850), received between Nov 29, 2021 and Sep 25, 2026 — classified as 1 death, 9 injuries, 461 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (150 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 26, 2023Open, Classified

   Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

   Z-2526-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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-2140-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 471 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026No Flow

  Hamilton Medial AG received the following complaint description (summary):It was reported that during patient transport from the ambulance HAMILTON-T1 to the hospital HAMILTON-T1, the user reported that the ventilator was not delivering breaths and that no waveforms or volume/min values were displayed. The patient was manually bagged to facilitate oxygenation. Another ventilator was used. The patient was ventilated in Pressure/SIMV mode on the replacement ventilator.The patient¿s oxygen saturation decreased to 85% and subsequently increased to 93% following manual bagging.Note: Hamilton Medical AG¿s investigation is ongoing to verify the allegation reported in the complaint.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50893915 ↗
• MalfunctionSep 24, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885235 ↗
• MalfunctionJul 3, 2026Excess Flow or Over-Infusion; Tidal Volume Fluctuations

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "DURING CLINICAL USE ON AN INTUBATED PATIENT, A HAMILTON TRANSPORT VENTILATOR INITIALLY FUNCTIONED NORMALLY AND DELIVERED REALISTIC VENTILATION PARAMETERS AFTER ALL REQUIRED PRE-USE CHECKS, INCLUDING CIRCUIT VERIFICATION ACCORDING TO UPDATED INSTRUCTIONS. SUDDENLY DURING PATIENT TREATMENT, THE VENTILATOR BEGAN DELIVERING ABNORMALLY RAPID VENTILATION WITH VERY LOW TIDAL VOLUMES (APPROXIMATELY 60 ML). THIS WAS FOLLOWED BY INTERMITTENT APNEA PERIODS. THE DEVICE THEN CONTINUED ALTERNATING BETWEEN RAPID VENTILATION WITH LOW TIDAL VOLUMES AND PAUSES IN VENTILATION. THE PATIENT WAS IMMEDIATELY SWITCHED TO MANUAL VENTILATION, AND THE VENTILATOR WAS REPLACED WITH ANOTHER HAMILTON DEVICE. THE REPLACEMENT DEVICE FUNCTIONED NORMALLY WITHOUT RECURRENCE OF THE ISSUE. SUBSEQUENT TESTING OF THE AFFECTED VENTILATOR, INCLUDING STANDARD FUNCTIONAL TESTS AND CIRCUIT CHECKS, SHOWED NORMAL PERFORMANCE, AND THE FAULT COULD NOT BE REPRODUCED. THE BREATHING CIRCUIT WAS ALSO REPLACED. ALL VENTILATORS IN THE UNIT HAD RECENTLY UNDERGONE MAINTENANCE." PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION, BUT NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703641 ↗
• MalfunctionJun 18, 2026No Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) IS DISPLAYING THE FOLLOWING TECHNICAL FAULTS: BLOWER FAULT, 446029, 485001. THEN VENTILATOR HAS STOPPED WORKING AND DISPLAYING THESE MESSAGES. NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544703 ↗
• MalfunctionJun 16, 2026Failure to Sense; Pressure Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) EXHIBITED A 231022 ERROR CODE DURING NEO THERAPY. THE EXACT DATE AND TIME OF THE EVENT IS UNKNOWN. THIS IS THE SECOND TIME IN X WEEKS' TIMEFRAME THAT THIS EVENT OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A LOSS OF PRESSURE WHILE RUNNING NCPAP ON A TRANSPORT FLIGHT, WITH THE REPORTED EVENT DATE OF APRIL 26, 2026. MEDICAL INTERVENTION WAS REPORTED, BUT OF UNKNOWN NATURE. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (UNKNOWN NATURE), BUT WITHOUT PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518265 ↗
• MalfunctionJun 16, 2026Inadequate User Interface; No Flow; No Visual Prompts/Feedback

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN: 161006 / SN: (B)(6) FAILED TO VENTILATE DURING USE/WHILST THE STAFF WAS PREPARING THE PATIENT FOR TRANSFER. DISCONNECTED FROM WALL OXYGEN PORT TO ATTACH OXYGEN BOTTLE. THE VENTILATOR STOPPED DELIVERING BREATHS. RE-ATTACHED TO WALL, BUT THE VENTILATOR DID NOT RESTART. WHEN DISCONNECTED CIRCUIT FROM ET TUBE (ENDOTRACHEAL TUBE), NO AIR WAS FLOWING THROUGH THE CIRCUIT. SCREEN FROZEN AND STAFF WAS UNABLE TO CHANGE ANY VALUES. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (CHANGING TO A DIFFERENT HAMILTON-T1 VENTILATOR) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514960 ↗
• MalfunctionJun 12, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE INCIDENT OCCURRED ON THE VENTILATOR WITH FOLLOWING EQUIPMENT DETAILS: SERIAL NO# (B)(6) THE ERROR THAT OCCURRED WAS TECHNICAL EVENT: 232003. THIS ERROR OCCURRED WHILST PROVIDING HIFLOWO2 TO THE PATIENT WITH THE SETTINGS OF A FLOW RATE OF 30L/MIN AND OXYGEN OF 45%. THE ERROR APPEARED AT THE TOP OF THE SCREEN AND MADE A LOUD AUDIBLE WARNING NOISE AND THEN STOPPED PROVIDING OXYGENATION TO THE PATIENT AND WOULD NOT ALLOW ANY PARAMETERS OF THE SETTINGS TO BE ALTERED. THIS HAPPENED ROUGHLY 15-20 MINUTES AFTER STARTING THE HIFLOWO2 TREATMENT TO THE PATIENT. WE THEN TURNED THE VENTILATOR OFF AND TRANSITIONED TO A NON-REBREATHER OXYGEN MASK AND RESTARTED THE VENTILATOR TO TRY AND TROUBLE SHOOT THE ERROR. WE THEN SUBSEQUENTLY PERFORMED A DOPE PROCEDURE ON THE VENTILATOR AND HIFLOWO2 CIRCUIT TO ENSURE THAT THERE WAS NO PROBLEM. THIS "DOPE" PROCEDURE INCLUDED ENSURING THAT THE CIRCUIT AND NASAL PRONGS WEREN'T "D"ISPLACED; THAT THERE WAS NO "O"BSTRUCTION TO THE CIRCUIT OR IN THE PATIENTS NOSE; THAT THE PATIENT DID NOT HAVE A "PNEUMOTHORAX; AND TO CHECK THE "EQUIPMENT. NO HARM OR ADVERSE EVENT OCCURRED TO THE PATIENT AS THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482591 ↗
• MalfunctionMay 29, 2026No Flow

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION): "VENT TURNED OFF WHILE ON A PATIENT, STAFF MANUALLY BAGGED THE PATIENT OFF THE VENTILATOR. ALARMED WITH TF 485001, TF 446029, TF 446028, AND TE 246009. NO PATIENT HARM OCCURRED ACCORDING TO THE STAFF." THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329550 ↗
• MalfunctionApr 9, 2026Insufficient Flow or Under Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: CUSTOMER REPORTS O2 NOT BEING DELIVERED BY UNIT. REPEATED OXYGEN SUPPLY FAILED MESSAGES. NO HEALTH CONSEQUENCES OR IMPACT NO INTERVENTION NECESSARY, WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829273 ↗
• InjuryMar 17, 2026Gas/Air Leak

  THE PATIENTS O2 LEVELS BECAME VERY LOW BEFORE IT WAS NOTICED BY HOSPITAL STAFF. NOT KNOWN IF THE DEVICE DID NOT ALARM OR IF HOSPITAL MONITORING SYSTEM HAD AN ISSUE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24619841 ↗
• MalfunctionMar 9, 2026Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED A REPORT STATING THAT A PATIENT¿S OXYGEN LEVELS BECAME VERY LOW BEFORE HOSPITAL STAFF NOTICED IT. IT IS NOT KNOWN WHETHER THE VENTILATOR ALARMS WERE ACTIVATED OR WHETHER THE HOSPITAL MONITORING SYSTEM HAD AN ISSUE. THE INFORMATION WAS PROVIDED DURING A PHONE CALL WITH THE BIOMEDICAL DEPARTMENT. THE DEVICE HAS NOT YET BEEN EVALUATED AND WILL BE SENT TO TECHNICAL SUPPORT. THE BIOMEDICAL DEPARTMENT COULD NOT PROVIDE ADDITIONAL DETAILS ABOUT THE EVENT OR WHAT ACTIONS WERE TAKEN. ADDITIONAL DEVICE WAS REQUIRED AND HARM WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 24543826 ↗
• MalfunctionMar 6, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT HAMILTON MEDICAL AG RECEIVED INFORMATION THAT A HAMILTON-T1 TRANSPORT VENTILATOR WAS ASSEMBLED INCORRECTLY. THE DEVICE WAS SET UP WITH AN EXPIRATORY VALVE INTENDED FOR ADULT USE INSTEAD OF THE NEONATAL EXPIRATORY VALVE REQUIRED FOR THE SELECTED PATIENT GROUP. AFTER THE CHILD WAS PLACED ON THE TRANSPORT STRETCHER AND MECHANICAL VENTILATION WAS STARTED, VENTILATION DID NOT CONTINUE EFFECTIVELY AND THE PATIENT EXPERIENCED DESATURATION. THE CLINICAL TEAM SWITCHED IMMEDIATELY TO MANUAL BAG-MASK VENTILATION. THE DEVICE DISPLAYED A YELLOW VISUAL AND AUDIBLE ALARM INDICATING AN INCORRECT EXPIRATORY VALVE. TRANSPORT TO THE PICU WAS CARRIED OUT USING BAG-MASK VENTILATION. WHEN THE CHILD WAS LATER CONNECTED TO A CORRECTLY ASSEMBLED HAMILTON-C6 ON THE WARD, INSUFFICIENT TIDAL VOLUME AND ANOTHER DROP IN SATURATION WERE REPORTED, AND MANUAL VENTILATION WAS CONTINUED. VENTILATION WAS THEREFORE NOT MAINTAINED, AND THE PATIENT WAS HARMED.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 24529021 ↗
• MalfunctionMar 4, 2026Obstruction of Flow

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): AN ¿EXHALATION OBSTRUCTED¿ ALARM WAS REPORTED WITH PATIENT INVOLVEMENT, AND THE COMPLAINT INDICATED THAT MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, CONFLICTING INFORMATION WAS ALSO RECEIVED STATING THAT THE ALARM OCCURRED ONLY WHILE THE VENTILATOR WAS DISCONNECTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511516 ↗
• MalfunctionMar 2, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: VENTILATOR DOES NOT EXHALE MORE THAN 21% OF O2. WHEN O2 IS SET TO 30% OR MORE, "OXYGEN SUPPLY LOW" ALARM ENGAGES. - NO PATIENT INVOLVEMENT - NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480937 ↗
• MalfunctionFeb 16, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "WHILE USING THIS T1, THE MESSAGES ¿BLOWER FAILURE¿ AND ¿VENTILATION INTERRUPTED¿ SUDDENLY APPEARED, AND THE ALARM CONTINUED TO SOUND. BECAUSE THE HOSPITAL STAFF IMMEDIATELY REPLACED THE VENTILATOR, THE PATIENT WAS NOT HARMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342439 ↗
• MalfunctionJan 27, 2026Unintended Electrical Shock

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTED FROM THE BIOMED. "ON (B)(6) 2026 AT 04:08 OR EARLIER RT WAS SHOCKED WHILE HOLDING THE T1 TROLLEY HANDLE. DEVICE WAS DESCRIBED AS RUNNING ON BATTERY. RT RECEIVED EMERGENCY MEDICAL CARE DUE TO INCIDENT. WEATHER CONDITIONS AT THAT TIME WERE NEGATIVE SINGLE DIGIT F. VENT WAS ACTIVELY VENTILATING PATIENT AT THAT TIME. BYSTANDERS WITNESSES LOUD ZAP. MEASURED LEAKAGE FROM CO2 CONNECTION WHILE ON AC POWER IS 6 UA. THE DESCRIPTION STRONGLY SUGGESTS A LARGE ENVIRONMENTAL ELECTROSTATIC DISCHARGE EVENT IN MY OPINION, BUT I WOULD LIKE TO ENSURE THE DEVICE IS SAFE REGARDLESS." NO HEALTH CONSEQUENCES OR IMPACT. HOWEVER, RT RECEIVED EMERGENCY MEDICAL CARE DUE TO INCIDENT (DETAILS NOT KNOWN). THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR, NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: Electric Shock

  MAUDE report 24187264 ↗
• MalfunctionJan 21, 2026Defective Alarm; No Apparent Adverse Event

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DURING PATIENT USE, THE VENTILATOR GENERATED A CONTINUOUS NON-SILENCEABLE ALARM AND WAS REPORTED AS FAILED. THE PATIENT WAS MANUALLY VENTILATED WHILE A REPLACEMENT VENTILATOR WAS DEPLOYED. THE FAULTY UNIT CONTINUED TO EMIT A PERSISTENT ALARM TONE EVEN AFTER REMOVAL FROM THE PATIENT. ERROR CODES: 'TECHNICAL EVENT: 246005", FOLLOWED BY TF 485001, TF 431001, TF 446029; 'VENTILATION CANCELLED'" NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130954 ↗
• MalfunctionJan 20, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "T1 VENTILATOR THAT STOPPED VENTILATING DURING TRANSPORT. THE FULL DESCRIPTION OF THE EVENT FROM CLINICAL STAFF IS AS FOLLOWS: ¿EVENT OCCURED DURING PAITENT TRANSPORT FROM MSJ ED TO SPH ICU. PT WAS INTUBATED AND VENTILATED. ON ARRIVAL TO SPH THE VENTILATOR ALARMED "TURN FLOW SENSOR", VE DROPPED TO 0, AND ETCO2 ROSE TO 80MMHG. PLACED VENTILATOR ON STANDBY AND MANUALLY VENTILATED PT ON 15LPM. ETCO2 DECREASED TO ~60MMHG. PT TRANSPORTED FROM ENTRANCE OF SPH TO ICU MANUALLY VENTILATED.¿" NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

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

  MAUDE report 24112939 ↗
• MalfunctionJan 6, 2026Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "EVENT TIME AROUNT 16:00 HOURS, 12/20 UNIT TRANSPORTING PATIENT FROM HOSPITAL, SET PATIENT UP HAD NO ISSUES. UPON EXITING HOSPITAL VENTILATOR ALARMED CONTINUOUSLY. CREW WAS UNABLE TO SILENCE THE ALARM, MAKE SETTING CHANGES, NO BUTTONS WORKED WHEN PRESSED. REMOVED PATIENT FROM VENTILATOR AND PERFORMED VENTILATIONS WITH BVM, SECONDARY CREW WAS DISPATCHED TO BRING ANOTHER VENTILATOR. UNIT IN QUESTION WAS PULLED FROM SERVICE. NOTE: VENTILATOR SHOWS IN EVENTS TAB TF CODES: 785003, 446029,444004,485001. NO HEALTH CONSEQUENCES OR IMPACT - NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971788 ↗
• MalfunctionDec 12, 2025Failure to Deliver; Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DURING PATIENT USE, THE VENTILATOR GENERATED A CONTINUOUS NON-SILENCEABLE ALARM AND WAS REPORTED AS FAILED. THE PATIENT WAS MANUALLY VENTILATED WHILE A REPLACEMENT VENTILATOR WAS DEPLOYED. THE FAULTY UNIT CONTINUED TO EMIT A PERSISTENT ALARM TONE EVEN AFTER REMOVAL FROM THE PATIENT. ERROR CODES: 'TECHNICAL EVENT: 246005", FOLLOWED BY TF 485001, TF 431001, TF 446029; 'VENTILATION CANCELLED'" NO HEALTH CONSEQUENCES OR IMPACT - THE PATIENT WAS MANUALLY VENTILATED WHILE A REPLACEMENT VENTILATOR WAS DEPLOYED. 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 23789425 ↗
• MalfunctionDec 12, 2025Obstruction of Flow; Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "BIOMED STATES THAT DURING VENTILATION, DEVICE WAS GETTING EXHALATION OBSTRUCTED ALARMS AND COULD NOT CLEAR THEM. LOOKS LIKE DEVICE WAS SWAPPED FOR ANOTHER." NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR, NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786828 ↗
• MalfunctionDec 10, 2025Improper Flow or Infusion; Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "FLOW SENSOR CALIBRATION FAILURE. LOGFILES SHOW CHECK FLOW SENSOR TUBING ERRORS AS WELL. FLOW SENSOR MOST LIKELY DISCONNECTED." NO HEALTH CONSEQUENCES OR IMPACT. PATIENT MOVED TO SEPARATE VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765434 ↗
• MalfunctionNov 28, 2025Intermittent Loss of Power; Intermittent Loss of Power

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "HAMILTON T1 VENTILATOR SN 10120. THE UNIT HAS BEEN REPORTED TO STOP WORKING WITH BLACK SCREEN FOR 15 SECONDS DURING A PATIENT CARE EPISODE. FOLLOWING THIS 15 SECONDS IT RETURNED WORKING AGAIN." NO HEALTH CONSEQUENCES OR IMPACT - NO INTERVENTION NECESSARY. 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 23669980 ↗
• MalfunctionNov 4, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "REPORT FAULT BY END USER ¿ VENTILATOR WAS LEAKING AIR, BUT NO MESSAGE WAS FLASHING. PRE-OP CHECKS AND TEST LUNG DONE WITHOUT ALARMS, HOWEVER, CUSTOMER WOULD STILL LIKE THIS TO BE CHECKED OVER. T1 VENTILATOR WAS WORKING WELL FOR 1 HOUR BUT PRIOR TO LEAVING ITU LEAKING OF AIR WAS NOTED BUT NO CHANGES WITH THE NUMBERS. BEFORE CT WAS STARTED, T1 VENT WAS PLAYING UP AGAIN WITH LEAKING OF AIR NOTED AGAIN. AGAIN NO CHANGES WITH THE NUMBERS AND NO MESSAGE FLAG UP. PATIENT STOP VENTILATING AT ONE POINT, WENT BRADYCARDIC 45 BPM WITH BIGEMENIES. INCIDENT DATE & TIME - (B)(6) 2025 TIME ¿ 14:40HRS". NO HEALTH CONSEQUENCES OR IMPACT. NO INTERVENTION NECESSARY. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23461862 ↗
• MalfunctionOct 29, 2025Failure to Deliver; Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "THIS T1 SUDDENLY SWITCHED TO AMBIENT MODE WHILE IN USE ON A PATIENT. HOSPITAL STAFF IMMEDIATELY REPLACED THE VENTILATOR, BUT THE PATIENT'S SPO2 TEMPORARILY DROPPED TO 60%." NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET. SO FAR, NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23412548 ↗