HAMILTON-T1 161009Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 07630002806091), received between Mar 10, 2022 and Jun 26, 2026 — classified as 3 deaths, 4 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 reports).

1 FDA recall record name this device's identifier, 1 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-2527-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (QUOATATION): "CUSTOMER REPORTS MULTIPLE "PATIENT DISCONNECT" ALARMS, WHILE ATTEMPTING TO USE ON PATIENT." PATIENT WAS INVOLVED, PATIENT HAD TO BE BAGGED. NO PATIENT, USER, THIRD PARTY HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633477 ↗
• MalfunctionMay 19, 2026Image Orientation Incorrect

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DISPLAY IS INVERTED WHEN UNIT POWER ON - NO PATIENT INVOLVEMENT - NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212392 ↗
• MalfunctionApr 7, 2026Insufficient Flow or Under Infusion

  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 AND NO INTERVENTION NECESSARY WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799493 ↗
• MalfunctionApr 2, 2026Insufficient Flow or Under Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (SUMMARY): THE VENTILATOR WAS REPORTED TO DELIVER NO MORE THAN 21 PERCENT OXYGEN, EVEN WHEN HIGHER OXYGEN LEVELS WERE SET. WHEN THE OXYGEN SETTING WAS INCREASED TO 30 PERCENT OR MORE, THE ALARM ¿OXYGEN SUPPLY LOW¿ ACTIVATED. NO PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. NO PATIENT, USER OR THIRD PARTY HARMED NOR A MEDICAL INTERVENTION (VENTILATOR REPLACEMENT) WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766259 ↗
• MalfunctionMar 26, 2026Optical Obstruction

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT STATING THAT DURING PATIENT VENTILATION THE VENTILATOR GENERATED AN EXHALATION OBSTRUCTION ALARM AND TECHNICAL EVENT 233002 (PVENT_CONTROL AUTOZERO FAILED). A PATIENT WAS INVOLVED, BUT NO HARM OCCURRED. NO HEALTH CONSEQUENCES, NO IMPACT, AND NO CLINICAL INTERVENTION WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696367 ↗
• MalfunctionMar 16, 2026Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE VENTILATOR DISPLAYED THE MESSAGE ¿RELEASE VALVE DEFECTIVE¿ WHILE IT WAS BEING USED ON A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS IMMEDIATELY REMOVED FROM THE DEVICE AND WAS MANUALLY VENTILATED WITH A BAG UNTIL A FUNCTIONING VENTILATOR WAS PROVIDED. IT WAS REPORTED THAT NO PATIENT HARM OCCURRED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602636 ↗
• 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. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480532 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH "EXHALATION OBSTRUCTED" ALARM AND "HIGH-PEEP" DURING PATIENT VENTILATION. NO HEALTH CONSEQUENCES OR IMPACT AN ADDITIONAL DEVICE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412797 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH "EXHALATION OBSTRUCTED" ALARM AND "HIGH-PEEP" DURING PATIENT VENTILATION. NO HEALTH CONSEQUENCES OR IMPACT AN ADDITIONAL DEVICE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412457 ↗
• MalfunctionFeb 20, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "THE CREW COMPLETED DAILY PREOP CHECKS THAT MORNING, WHICH PASSED. THE CREW ATTACHED THE VENT TO THE PATIENT FOR TRANSPORT. WHEN IT FAILED THE FIRST TIME, THEY TROUBLESHOT IT WITHOUT SUCCESS AND MADE A 2ND ATTEMPT WITH THE SAME CIRCUIT, WHICH FAILED AGAIN. THEY THEN SWITCHED TO A NEW CIRCUIT AND EXPIRATORY VALVE, AND IT FAILED AGAIN WITH THAT 2ND CIRCUIT AND A NEW EXPIRATORY VALVE. THEY ALSO CHECKED AND RECHECKED ALL CONNECTIONS AND ENSURED THAT THERE WERE NO LOOSE CONNECTIONS AND THAT EVERYTHING WAS HOOKED UP APPROPRIATELY. WHEN THEY GOT BACK TO BASE, I FACETIMED WITH THEM AND SAW THE FAILURE. WE CONFIRMED SETTINGS AND CONNECTIONS, AND THE VENT FAILED. SO, THEY SWITCHED TO A NEW CIRCUIT AND EXPIRATORY VALVE AND IT FAILED AGAIN. THIS IS THE 2ND TIME THAT THIS SAME VENT HAS BEEN SENT BACK TO HAMILTON FOR THE SAME ISSUES. 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 24399546 ↗
• MalfunctionFeb 17, 2026Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT STATING THAT DURING PATIENT TRANSPORT A HAMILTON-T1 VENTILATOR PRODUCED A CONSTANT HIGH-PITCHED ALARM SOUND, THE DISPLAY FROZE, AND VENTILATION STOPPED. ACCORDING TO THE CUSTOMER, NEITHER THE TOUCHSCREEN NOR THE HARDWARE CONTROLS RESPONDED, AND THE DEVICE WAS RESTARTED BY A HARD SHUTDOWN, AFTER WHICH VENTILATION RESUMED NORMALLY. NO ADDITIONAL DEVICE WAS REQUIRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362962 ↗
• MalfunctionDec 22, 2025No Display/Image; No Display/Image

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "BIOMED SAYS, HOSPITAL STAFF REPORTED THAT DURING VENTILATION, THE SCREEN WENT BLANK AND THE DEVICE ALARMED. THAT'S ALL THE INFORMATION GIVEN." 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 23862964 ↗
• MalfunctionDec 8, 2025Pressure Problem; Pressure Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "THE MT1 WAS VENTILATING A PATIENT DURING TRANSPORT AND A LOT OF PATIENT ALARMS OCCURED. MAINLY DISCONNECTION ON PATIENT SIDE, EVEN THOUGH THE PATIENT CIRCUIT AND FLOW SENSOR WERE CONNECTED AND THE PATIENT WAS ALSO CONNECTED. ALSO, A LOT OF PRESSURE LIMITATIONS AND HIGH FREQUENCY ALARMS AS WELL OF COURSE. I LOOKED WHEN THEY DID THE LEAK TEST AND THE FLOW SENSOR TEST AND IT WAS RIGHT BEFORE THE CASE ON THE SAME DAY. I WONDER IF IT COULD BE USER RELATED IN A WAY BUT AT THE SAME TIME, AN RT NOT ON THAT CASE REDID THE FLOW SENSOR AND LEAK TEST WITH BRAND NEW PATIENT CIRCUIT AND STILL SAW THE SAME PROBLEM WITH A LUNG TEST. HE ALSO TRIED THREE DIFFERENT LUNG TESTS AND A DIFFERENT EXPIRATORY VALVE.". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742676 ↗
• MalfunctionNov 24, 2025Unexpected Mode Switch; Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "CUSTOMER SAID VENT STOPPED WORKING AND SHOWED "SAFETY VENTILATION ERROR 8". I SEARCHED THE LOG FILES AND FOUND 3 TF CODES: 346054, 341009, AND 385002. ANOTHER VENT WAS BROUGHT TO THE USERS. PATIENT WAS REPORTED TO NOT HAVE ANY ISSUES WHILE WAITING." NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631584 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "(B)(6) CALLED IN REGARDS TO A HAMILTON C1 SN (B)(6) WHICH SUDDENLY HAD A BLANK/BLACK SCREEN DURING THERAPY. THERAPY WAS NOT INTERRUPTED DURING THAT TIME, JUST THE SCREEN REMAINING BLANK. RT 'WHACKED' THE SCREEN AND IT RETURNED MOMENTARILY. ISSUED REQUEST TO HAVE FIELD ENGINEER SERVICE DEVICE AND EXTRACT LOGS, SENT QUESTIONNAIRE TO CUSTOMER." 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 23631336 ↗
• MalfunctionOct 15, 2025Unexpected Shutdown; Unexpected Mode Switch; Unexpected Shutdown; Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: ORIGINAL NOTE FROM CUSTOMER "T1 VENTILATOR ON A PATIENT GOING INTO STANDBY AFTER MAKING A LOUD NOISE. THIS OCCURRED AT THE OC ICU." NOTE ON THE MACHINE ALSO SAID SEPT 7TH - ALARMING LOW VT AND MINUTE VOLUMES, DESPITE PASSING FLOW SENSOR TEST AND LEAK TEST. RT UNABLE TO TROUBLESHOOT" 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 23299223 ↗
• MalfunctionAug 21, 2025Communication or Transmission Problem; Failure of Device to Self-Test; Communication or Transmission Problem; Failure of Device to Self-Test

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DEVICE SHOWED UP TE231013 WHILE VENTILATING A PATIENT ON THE PLANE (REGA)". INTERVENTION WAS NECESSARY AND THE VENTILATOR WAS CHANGED FOR ANOTHER ONE. HAMILTON MEDICAL AG ADDITION: A FIRST REVIEW OF THE LOG FILES SHOWED THAT THE TE231013 OCCURRED ALREADY DURING SELF TEST PRIOR TO USAGE OF THE DEVICE ON PATIENT. FURTHER INFORMATION/CLARIFICATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858032 ↗
• MalfunctionJul 15, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DEVICE CAME IN WITH TES 231022 AND 231036 AND TFS 444004, 431002 & 285002. IT WAS ALSO FAILING THE SELF TEST. THE CONTROL BOARD AND DRIVER BOARD WERE REPLACED. ALL CODES CLEARED AND ALL TESTS PASSED. DEVICE HAS GONE BACK INTO SERVICE." NO PATIENT INVOLVEMENT. 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 22505439 ↗
• MalfunctionJul 14, 2025Unexpected Mode Switch; Unexpected Mode Switch

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "BIOMED STATES THAT DURING VENTILATION THE STATED ALARMING SHOWED TECH FAULTS AND THEN SHUT DOWN. PATIENT WAS REMOVED FROM DEVICE AND MANUALLY 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 22492250 ↗
• MalfunctionJul 9, 2025No Flow; No Flow

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "END USER OF DEVICE SAYS AFTER 15 MINUTES OF USE, THE DEVICE STOPPED DELIVERING BREATHS. LOW MINUTE VOLUME AND OXYGEN SUPPLY FAIL." THE PATIENT HAD TO BE TEMPORARILY BAGGED. HOWEVER, NO HEALTH CONSEQUENCES OR IMPACT OCCURRED. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET AND SO FAR, NO RELATION TO THE DEVICE HAS BEEN ESTABLISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456045 ↗
• MalfunctionJun 3, 2025Failure to Charge; No Flow; Failure to Charge; No Flow

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DURING TRANSPORT, DEVICE MALFUNCTIONED SENDING A CRITICAL BATTERY DISCONNECT ERROR AND STOPPED VENTILATING, THEY ATTEMPTED TO TROUBLE SHOOT BY PLUGGING THE DEVICE INTO WALL PLUG, BUT THAT DID NOT RESOLVE THE ISSUE." NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET; THEREFORE, THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129709 ↗
• MalfunctionMay 26, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING VENTILATION OF THE PATIENT, THE HAMILTON-T1 VENTILATOR DEVICE ALARMED FOR PEEPLOW AND TURN-FLOW SENSOR. NO DEVICE LOG FILES ARE PROVIDED TO HAMILTON MEDICAL. THE VENTILATOR DEVICE GOT EXCHANGED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THE AVAILABLE INFORMATION REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, THIS EVENT IS ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084337 ↗
• MalfunctionMay 7, 2025Failure to Power Up; Failure to Power Up

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "VENT WILL NOT TURN ON WITH AC OR BATTERY POWER". THERE IS NO PATIENT INVOLVEMENT. THE VENTILATOR DEVICE MODEL HAMILTON-T1 IS DESIGNED TO USE FOR PATIENT TRANSPORTATION. IN THAT SPECIFIC CONFIGURATION, IF THE DEVICE WOULD BE URGENTLY NEEDED AND THERE IS A POWERING ISSUE, A CONSEQUENCE FOR A PATIENT WHEN VENTILATION IS URGENTLY NEEDED CANNOT BE EXCLUDED. THEREFORE, THE EVENT WAS ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974358 ↗
• MalfunctionMar 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE NEBULIZER PRESSURE TEST FAILED DUE TO A CONTINUOUS INCREASE IN PRESSURE." NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592511 ↗
• MalfunctionMar 11, 2025Improper Flow or Infusion; Insufficient Device Problem Information; Improper Flow or Infusion; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: QUOTATION FROM THE REPORTER: "ALARMS WITH ERROR CODE THAT PATIENT IS DISCONNECTED WHEN ALL LINES ARE SECURED TO PATIENT AND VENTILATOR. ISSUE OCCURRED WITH SEVERAL DIFFERENT CREW SHIFTS AND WHILE CONNECTED TO AN I-GEL AND ETT. OTHER ALARMS PRESENT INCLUDED LOW VOLUME / HYPOVENTILATION WITH EXTREMELY LOW VTE / MV VALUES NOTED ON SCREEN." NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570358 ↗