HAMILTON-T1 1610060Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 07630002813532), received between Mar 6, 2023 and Sep 29, 2026 — classified as 3 deaths, 9 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (29 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Loose or Intermittent Connection

  Hamilton Medial AG received the following complaint description (summary):It was reported that, during transport of an intubated patient to (b)(6) on (b)(6)2026, a HAMILTON-T1 (Product No. 161006, (b)(6), software version not reported) generated an alarm indicating that the oxygen supply was empty approximately 20 minutes before reaching Pori.According to the information provided, the transport had started with a full 10-liter oxygen cylinder. The patient was connected to the ventilator without reported difficulty, and no warnings or abnormal device behavior were reportedly observed before the oxygen supply alarm occurred.The transport stopped at a hospital, where the primary oxygen cylinder was replaced with an available spare cylinder. Ventilation was continued using the same HAMILTON-T1. The complaint records medical intervention as ¿Yes¿ and states that ventilation during transport was completed using the spare oxygen cylinder. No patient, user or third-party harm or adverse clinical outcome was reported.The user reported hearing a leak near the plastic retaining nut securing the return hose. According to the user, the expiratory valve had not been fully tightened, and the repo

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930188 ↗
• MalfunctionSep 29, 2026Inaccurate Delivery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928494 ↗
• MalfunctionSep 25, 2026Inaccurate Delivery

  It was reported to Hamilton Medical AG, that: "SIMV not ventilating patient and showing minimal to none VTE. Complete failure on patient flight. SIMV-TV 450, VTE showed 125 with high PIPs. Pressure mode 18/8, returns low as well because of the lung compliance and unable to ventilate the patient with the vent. He tried smart mode and VTE improved but alerts with "ASV unable to reach limit". Due to the respiratory patient condition, they tried the vent again on a patient without any respiratory issues and had the same failures. We had this same issue with a vent at Delta SN (b)(6) currently being evaluated by your team."Patient involvement, but without patient, user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895312 ↗
• MalfunctionSep 17, 2026Circuit Failure

  It was reported to Hamilton Medical AG, that: "INTERMITTENT ISSUES, INCLUDING SPONTANEOUS MODE CHANGE, SCREEN LOCKING UP AND ODD ALARMS (VT, AND MINUTE VOLUME) PER TECH SUPPORT, CHANGE CONTROL BOARD AND PRESSURE SENSOR ASSEMBLY."No patient involvement and no user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803847 ↗
• MalfunctionAug 27, 2026Obstruction of Flow

  Hamilton Medial AG received the following complaint description (summary): It was reported that a HAMILTON-T1 ventilator (Product No. 1610060, S/N (b)(6), SW 3.1.1) repeatedly generated an "Exhalation Obstruction" alarm on (b)(6) 2026 while connected to a CCT (Critical Care Transport) isolette. The issue was reported to have occurred with multiple breathing circuits from different lot numbers, and the most recently affected circuits remained attached to the isolette at the time of reporting. No patient, user, or third-party harm was reported. A medical intervention was indicated; however, no further details were provided. The investigation to verify the allegation is still in progress.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472498 ↗
• DeathJun 24, 2026Insufficient Device Problem Information

  UNKNOWN DATE OF DEATH. CUSTOMER STATES VENTILATOR WAS INVOLVED IN A SENTINEL EVENT. T.

  Patient problems: Insufficient Information

  MAUDE report 25616120 ↗
• InjuryJun 2, 2026Insufficient Flow or Under Infusion

  DURING PATIENT CARE HAMILTON VENTILATOR BEGAN TO ALARM "LOW OXYGEN". O2 SOURCE WAS CHECKED AND CONFIRMED ON PORTABLE O2 TANK. VENTILATOR WAS THEN PLACED ON THE ONBOARD AIRCRAFT OXYGEN SYSTEM, LOW O2 ALARMS CONTINUED. ADDITIONAL PORTABLE TANK ATTEMPTED AND LOW O2 ALARMS PERSISTED. DURING FLIGHT "FAILED O2 SOURCE" ALARM. PATIENT BEGAN TO DESATURATE DURING FLIGHT - THIS WAS AFTER 10 MINS OF CONTINUOUS ALARMS AND TROUBLESHOOTING. PATIENT WAS REMOVED FROM VENT AND BAGGED WITH BVM ON 15LPM. VENT WAS CHECKED - ALL CONNECTIONS, HOSES, O2 SOURCES VERIFIED - OXYGEN TANK FULL. ONBOARD OXYGEN WAS RUNNING- UNABLE TO RESOLVE THE ISSUE. ADDITIONAL INFO PROVIDED: 1.AIRCRAFT O2 INTERFACE/REGULATOR MODEL: ESSEX MEDICAL SYSTEMS PLUS 2. HOSE TYPE, AND INFORMATION ON WHETHER A QUICK-CONNECT WAS USED: HIGH PRESSURE O2 LINE (MEDICAL OXYGEN RESPIRONICS REORDER # (B)(4)) AND THERE WAS NO QUICK-CONNECT SYSTEM USED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25362209 ↗
• MalfunctionJun 1, 2026Loose or Intermittent Connection

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (QUOTATION): EQUIPMENT O2 ALARM, DURING PATIENT CARE AND TRANSPORT, AS WELL AS "PATIENT DISCONNECT" ERRORS. THERE WAS NO REPORT OF HARM TO PATIENT, USER OR THIRD PARTY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347160 ↗
• MalfunctionMay 29, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 1610060 / SN (B)(6) IS CONTINUOUSLY ALARMING FOR OBSTRUCTION FAILURE. THE UNIT WILL NOT AUTOZERO IN SERVICE MODE. THIS IS A REPEAT PROBLEM WITH THIS PARTICULAR HAMILTON-T1. THE MSP161265 EXHALATION VALVE ASSEMBLY WAS ORDERED. THE REPORTED EVENT DATE IS MAY 7TH, 2026. NO PATIENT INVOLVEMENT, MEDICAL INTERVENTION OR PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330495 ↗
• InjuryMay 13, 2026Improper Flow or Infusion

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: DURING PATIENT TRANSPORT ON (B)(6) 2026 THE HAMILTON-T1 CONFIGURED VENTILATOR (PN 1610060 / SN (B)(6) GENERATED REPEATED ¿LOW OXYGEN¿ ALARMS DESPITE CONNECTION TO A VERIFIED PORTABLE OXYGEN CYLINDER. THE VENTILATOR WAS SUBSEQUENTLY CONNECTED TO THE ONBOARD AIRCRAFT OXYGEN SYSTEM; HOWEVER, THE ALARMS PERSISTED. A SECOND PORTABLE OXYGEN TANK WAS ATTEMPTED WITHOUT RESOLUTION. DURING FLIGHT, A ¿FAILED O2 SOURCE¿ ALARM OCCURRED. AFTER APPROXIMATELY 10 MINUTES OF CONTINUOUS ALARMS AND TROUBLESHOOTING, THE PATIENT BEGAN TO DESATURATE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED USING A BAG-VALVE-MASK (BVM) WITH 15 L/MIN OXYGEN. ALL VENTILATOR CONNECTIONS, HOSES, AND OXYGEN SOURCES WERE CHECKED AND CONFIRMED, WITH OXYGEN SUPPLY AVAILABLE FROM BOTH PORTABLE TANKS AND THE ONBOARD SYSTEM; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE AIRCRAFT OXYGEN INTERFACE/REGULATOR USED WAS AN ESSEX MEDICAL SYSTEMS PLUS, AND A HIGH-PRESSURE OXYGEN HOSE (RESPIRONICS REORDER #(B)(4) WAS UTILIZED WITHOUT A QUICK-CONNECT SYSTEM. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (REMOVAL FROM VENTIL

  Patient problems: Low Oxygen Saturation

  MAUDE report 25157988 ↗
• MalfunctionApr 2, 2026Gas/Air Leak

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT THAT A PATIENT WAS VENTILATED WITH A HAMILTON-T1 IN NIV-ST MODE ON 22.03.2026 BETWEEN 09:35 AND 11:05. THE USER REPORTED MINIMAL LEAKAGE AND NOTED THAT THE PATIENT HAD A LIGHT BEARD. APPROXIMATELY 2000 LITERS OF OXYGEN AVAILABLE IN THE AMBULANCE WERE DEPLETED AFTER ABOUT 21 MINUTES. SWITCHING TO A RESERVE OXYGEN CYLINDER RESTORED SUPPLY. UPON ARRIVAL AT THE HOSPITAL, A PORTABLE 2-LITER OXYGEN CYLINDER WAS CONNECTED AND WAS ALSO RAPIDLY DEPLETED. THE PATIENT WAS SUBSEQUENTLY HANDED OVER TO HOSPITAL STAFF WITHOUT MEDICAL INTERVENTION. THE HIGH-PRESSURE OXYGEN COUPLING WAS REPORTED TO BE ICED, AND THE USER EXPRESSED CONCERN THAT THE VENTILATOR MAY HAVE DRAWN EXCESSIVE OXYGEN. NO PATIENT HARM OR ADVERSE HEALTH EFFECTS WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765167 ↗
• MalfunctionMar 30, 2026Obstruction of Flow

  "VENTILATOR PASSED PRE-OP CHECKS, PUT ON PATIENT...ALARM EVIDENT "EXHALATION OBSTRUCTION - LOW MINUTE VOLUME". STAFF CHANGED PATIENT TO DIFFERENT VENT (DRAGER V800)...PATIENT VENTILATED OK. RETRIEVED SPARE T1 VENTILATOR, PASSED PRE-OP, TRANSFERRED PATIENT TO THIS T1 OK. STAFF CHECKED FIRST T1 (B)(6) AGAIN, PUT ON A TEST LUNG...INITIALLY DIDN'T VENTILATE PROPERLY BUT RESOLVED AFTER 5 MINUTES AND VENTILATED OK." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729555 ↗
• MalfunctionMar 23, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE CIRCUIT WAS ATTACHED TO A PATIENT FOLLOWING SUCCESSFUL PRE-OPERATIVE CHECKS. UPON CONNECTING THE PATIENT, THE VENTILATOR DISPLAYED THE ERROR MESSAGE ¿BLOCKED EXPIRATORY VALVE¿, AND NO VENTILATION WAS DELIVERED. THE PATIENT WAS IMMEDIATELY REMOVED FROM THE CIRCUIT AND PLACED BACK ON A BEDSIDE VENTILATOR, WHERE VENTILATION WAS RESTORED WITHOUT ISSUES. THE CIRCUIT WAS THEN DISMANTLED, RECONNECTED, AND RE-CHECKED SUCCESSFULLY. HOWEVER, WHEN ATTACHING THE PATIENT A SECOND TIME, THE SAME ISSUE OCCURRED AGAIN. A NEW VENTILATOR AND CIRCUIT WERE OBTAINED. AFTER SUCCESSFUL PRE-USE CHECKS, THE PATIENT WAS CONNECTED, AND VENTILATION PROCEEDED NORMALLY WITHOUT FURTHER ISSUES. A SECOND INCIDENT INVOLVED A DIFFERENT PATIENT AND A DIFFERENT CIRCUIT, BUT THE SAME VENTILATOR. IN THIS CASE, THE VENTILATOR FAILED THE LEAK TEST. THE EXPIRATORY VALVE WAS REPLACED, THE CHECKS WERE COMPLETED SUCCESSFULLY, AND THE DEVICE OPERATED NORMALLY THEREAFTER. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660440 ↗
• MalfunctionMar 18, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE VENTILATOR SUDDENLY ALARMED, THE SCREEN WENT BLANK, VENTILATION STOPPED, AND UPON RESTART DISPLAYED ¿VENTILATION TERMINATED¿ DURING NEONATAL VENTILATION. THE PATIENT WAS TEMPORARILY VENTILATED MANUALLY USING A BVM (BAG-VALVE-MASK) UNTIL THE DEVICE RESTARTED AND FUNCTIONED NORMALLY AGAIN. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS. CUSTOMER REPORT: ¿WHILE ROLLING A STRETCHER WITH A VENTILATED NEONATE IN A BABY POD IN BRIGHT SUNLIGHT; THE VENTILATOR BEGAN AN URGENT TWO-TONE ALARM THAT NEITHER CREW MEMBERS HAD EVER HEARD. WE TURNED THE STRETCHER AWAY FROM THE SUN AND NOTED THAT THE VENTILATOR SCREEN WAS BLANK, BUT ALARMING. WE PUSHED THE POWER BUTTON AND THE SCREEN ILLUMINATED WITH A "VENTILATION TERMINATED" MESSAGE. THE PATIENT WAS TRANSITIONED TO A BVM WHILE WE TROUBLE SHOT THE VENTILATOR. VENTILATOR WAS TURNED OFF AND THEN BACK ON, TURNING BACK ON IN DEFAULT ADULT SETTINGS. THE NEONATE SETTINGS WERE REENTERED AND THE VENTILATOR PERFORMED NORMALLY. THE PATIENT WAS REATTACHED TO THE VENTILATOR AND TRANSPORT CONTINUED WITH NO FURTHER ALARMS OR ABNORMAL EVENTS. LIFE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625258 ↗
• MalfunctionMar 16, 2026Insufficient Flow or Under Infusion

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT CONCERNING A NEONATAL TRANSPORT DURING WHICH THE INFANT WAS VENTILATED IN NCPAP MODE AT 21% OXYGEN. THE INFANT SHOWED REDUCED OXYGEN SATURATION AND SHALLOW BREATHING, AND CLINICAL STAFF ATTEMPTED TO INCREASE THE OXYGEN CONCENTRATION TO 23% AND LATER TO 28%. ACCORDING TO THE REPORT, THE DELIVERED OXYGEN DID NOT INCREASE AND THE VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM. THE SAME BEHAVIOR OCCURRED WHEN A DIFFERENT OXYGEN CYLINDER WAS CONNECTED. THE TRANSPORT WAS COMPLETED USING EMERGENCY DRIVE MODE. THE INFANT STABILIZED WITH GENTLE STIMULATION, AND NO HEALTH CONSEQUENCES WERE REPORTED. LOGFILE DATA FROM 09 MARCH 2026 SHOWS REPEATED ¿OXYGEN SUPPLY FAILED¿ ALARMS FOLLOWING ATTEMPTS TO INCREASE OXYGEN ABOVE 21%. FUNCTIONAL CHECKS PERFORMED ON 09 MARCH 2026 DID NOT REVEAL ANY DEVICE ERRORS. NO FURTHER INFORMATION WAS PROVIDED YET. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603103 ↗
• MalfunctionMar 16, 2026Battery Problem

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT CONCERNING A RECENTLY PURCHASED BATTERY THAT SHOWED AN UNEXPECTED AND RAPID DECREASE IN ITS STATE OF HEALTH AFTER APPROXIMATELY FOUR MONTHS OF USE. LOGFILE DATA DOCUMENTED A DECLINE IN STATE OF HEALTH FROM 59.5 PERCENT TO 22.2 PERCENT AND SUBSEQUENTLY TO 0 PERCENT WITHIN A SHORT PERIOD. AFTER CALIBRATION, THE BATTERY REACHED ONLY ABOUT 30 PERCENT STATE OF HEALTH, AND A REDUCED CAPACITY WAS CONFIRMED. THE CUSTOMER STATED THAT THE BEHAVIOUR WAS ABNORMAL COMPARED WITH OTHER BATTERIES OF SIMILAR PRODUCTION. NO HEALTH CONSEQUENCES, NO IMPACT ON VENTILATION, AND NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602850 ↗
• MalfunctionMar 9, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE HAMILTION-T1 VENTILATOR ALARMING "EXHALATION OBSTRUCTION" AT START OF VENTILATION. NO HEALTH CONSEQUENCES OR IMPACT OCCURRED, WAS REPORTED. THE UNIT HAD TO BE REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543044 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED A REPORT STATING THAT DURING VENTILATION THE DEVICE GENERATED AN EXHALATION OBSTRUCTION ALARM TOGETHER WITH VT HIGH AND INSPIRATORY VOLUME LIMITATION. THE HOSPITAL¿S BIOMED DEPARTMENT CONFIRMED THAT THE SAME ISSUE HAD OCCURRED PREVIOUSLY WITH THIS DEVICE. THE MANUFACTURER REQUESTED CLARIFICATION REGARDING THE USE OF HUMIDIFIERS OR FILTERS. BIOMED LATER CONFIRMED THAT FILTERS WERE INSTALLED ON BOTH THE INSPIRATORY AND EXPIRATORY SIDE. NO HEALTH CONSEQUENCES OCCURRED AND NO CLINICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530317 ↗
• DeathFeb 13, 2026Insufficient Device Problem Information

  OXYGEN QUICK CONNECT ON PORTABLE TANK FAILED. HOSE FROM VENTILATOR APPEARED TO BE ATTACHED BUT APPARENTLY SLIPPED FROM THE CONNECTOR CAUSING PATIENT TO DESATURATE. UPON EVALUATION OF THE CONNECTOR AFTER THE CALL, IT WAS DISCOVERED THAT THE QUICK CONNECT WAS NOT PROPERLY LATCHING. HAVE A VIDEO SHOWING IT MALFUNCTIONING BUT WAS UNABLE TO LOAD DUE TO SIZE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24338999 ↗
• MalfunctionFeb 12, 2026Electrical /Electronic Property Problem

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): THE VENTILATOR REPORTEDLY SHUT OFF, DISPLAYED A BLANK SCREEN, AND COULD NOT BE POWERED DOWN UNTIL THE BATTERIES WERE REMOVED. AFTER REBOOTING, MULTIPLE TECHNICAL ERROR CODES WERE DISPLAYED. A TECHNICIAN WAS SCHEDULED TO INSPECT THE DEVICE ONSITE. THE RETURNED QUESTIONNAIRE INDICATED NO PATIENT INVOLVEMENT AND NO INTERVENTION NECESSARY. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320884 ↗
• MalfunctionFeb 10, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT DURING INVASIVE VENTILATION IN DUOPAP MODE AFTER RETURN OF SPONTANEOUS CIRCULATION, NO AIR REACHED THE PATIENT. THE DEVICE WAS STOPPED IMMEDIATELY, AND THE PATIENT WAS MANUALLY VENTILATED WITH A BAG. NO HARM WAS REPORTED. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302799 ↗
• MalfunctionJan 7, 2026Pressure Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "VENTILATOR UNABLE TO REACH PEEP." PRESSURES WERE BEING TESTED PRIOR TO PATIENT USE. USED SAME SETUP AND SETTINGS. VERIFIED UNABLE TO REACH EXPECTED PEEP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987552 ↗
• MalfunctionDec 1, 2025No Flow; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "INTUBATED A PATIENT IN RESUS -AT FIRST CO2 CAME UP AND GOOD CHEST RISE WITH SATS 92%. APPROX 10 MIN AFTER CLINICAL STAFF NOTICED THERE WAS NO CO2 ON MONITOR, THEN CHECKED FOR CHEST RISE AND WASN'T PRESENT. SEEMS VENT NOT WORKING AND THEY TOOK OVER MANUAL VENTILATION AND VENTILATOR REPLACED FOUND VENTILATION WORKING." 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: Hypoventilation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678011 ↗
• MalfunctionOct 16, 2025No Audible Prompt/Feedback; No Visual Prompts/Feedback; No Audible Prompt/Feedback; No Visual Prompts/Feedback

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "HOSPITAL STAFF SAYS THAT DURING VENTILATION, SCREEN FROZE AND ALARMED AND COULD NOT BE CLEARED. DEVICE DID SHOW SOME TECH FAULTS, 746002 & 346054. PATIENT WAS REMOVED FROM DEVICE AND BAGGED." 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 23309537 ↗
• MalfunctionSep 17, 2025Misconnection; Misconnection

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "PATIENT WAS BEING VENTILATED IN EMERGENCY DEPARTMENT (ED) ON A T1. DURING THIS THE 'FLIP FLOW SENSOR' ALARM WAS INTERMITTENTLY ACTIVATING. INCIDENT OCCURRED ON WED. (B)(6). HOSPITAL STAFF REPORTS TIDAL VOLUMES DROPPED AND PATIENT MONITORED ETCO2 INCREASED. PATIENT WAS REMOVED FROM VENTILATOR AND MANUALLY BAGGED. (THIS CASE IS REPORTED UNDER MFR NR: 3001421318-2025-00809, HAMILTON MEDICAL REF NR: (B)(4) PATIENT PUT ON A SECOND T1 VENTILATOR WITH A NEW CIRCUIT AND FLOW SENSOR. "FLIP FLOW SENSOR" ALARM OCCURRED AGAIN ON THE SECOND VENTILATOR ON ARRIVAL TO ICU IN TRANSFER AND PATIENT REQUIRED TO BE MANUALLY BAGGED AGAIN. (THIS IS ADDRESSED IN THIS CASE) BOTH VENTS HAD PASSED PREOP TEST BEFORE USE INCLUDING THE FLOW SENSOR TEST AS PER USER MANUAL. 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: Hypoventilation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070497 ↗