HAMILTON-MR1 1610100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630002813556), received between May 12, 2023 and Dec 12, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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-2528-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Deliver; No Flow; Failure to Deliver; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE REMOVING A PATIENT FROM A CT SCAN, THE DEVICE CANCELED VENTILATION, AND THE EVENT LOG RECORDED TECHNICAL FAULTS 446029 (AMBIENT FAILURE DETECTED), 485001 (AMBIENT FAILURE DETECTED) AND 431001 (BLOWER FAULT). THE CUSTOMER ALSO REPORTED THE TESLASPY INDICATOR FLASHED YELLOW DESPITE THE INCIDENT OCCURRING IN A CT ENVIRONMENT (NOT THE MRI SUITE). NO PATIENT HARM WAS REPORTED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786816 ↗
• MalfunctionJul 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: ACCORDING TO THE COMPLAINT, THE PRETESTS OF THE VENTILATOR PASSED. HOWEVER, WHEN THE VENTILATION WAS INITIATED ON PATIENT, THERE WAS NO VISIBLE SIGN OF CHEST MOVEMENT. RETURN TIDAL VOLUMES WERE 30-50ML WHEN THE VENTILATOR WAS SET AT 400ML. THE VENTILATOR WAS EXCHANGED, AND THE PATIENT HAD NORMAL CHEST MOVEMENT AND RETURN TIDAL VOLUMES WERE CORRECT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505268 ↗
• MalfunctionFeb 21, 2025Insufficient Cooling; Electrical /Electronic Property Problem; Insufficient Cooling; Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DEVICE FAILED FOR THE CHECK VALVE AND LEAK TESTS. THE FAN IS DEFECTIVE". THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. WHEN A VENTILATOR DEVICE DOESN¿T START-UP THAT COULD LEAD TO DESATURATION (SPO2 80-87%) WHAT MAKES THIS CASE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431870 ↗
• MalfunctionJan 28, 2025Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  BOTH BATTERIES ARE DISLODGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252145 ↗
• MalfunctionNov 25, 2024Failure to Interrogate; Failure to Power Up; Failure to Interrogate; Failure to Power Up

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "AT POWER-UP UNIT ALARMED FOR HARDWARE PARAMETER FILE READ FAILED". - THIS OCCURRENCE WAS NOTICED AT START-UP DURING THE BOOTING PROCESS OUTSIDE THE BIOMED SHOP. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772447 ↗
• MalfunctionNov 25, 2024Failure to Interrogate; Failure to Power Up; Failure to Interrogate; Failure to Power Up

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "AT POWER-UP UNIT ALARMED FOR HARDWARE PARAMETER FILE READ FAILED". THIS OCCURRENCE WAS NOTICED AT START-UP DURING THE BOOTING PROCESS OUTSIDE THE BIOMED SHOP. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772404 ↗
• MalfunctionNov 14, 2024Improper or Incorrect Procedure or Method; Gas/Air Leak; Improper or Incorrect Procedure or Method; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "VENTILATOR SHUTDOWN DURING PATIENT USE. PATIENT WAS IN THE MRI SUITE AND THE VENTILATOR STOPPED ACTIVELY VENTILATING. AIR WAS GOING INTO THE CIRCUIT BUT NOT REACHING THE PATIENT. THE ERROR MESSAGE READ EXPIRATORY FLOW SENSOR FAILURE.". IT IS NOT KNOWN IF THE DEVICE WAS POSITIONED TOO CLOSE TO THE MRI SCANNER. THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. HAMILTON MEDICAL AG HAS NOT RECEIVED ANY FURTHER INFORMATION ON THIS. NO HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681729 ↗
• MalfunctionOct 22, 2024Electrical /Electronic Property Problem; Smoking; Failure to Deliver; Electrical /Electronic Property Problem; Smoking; Failure to Deliver

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "TECHNICAL FAILURE TF 431002 (BLOWERDISCONNECTED) AND A BURNING SMELL WAS NOTICED)". THE LOG FILES INDICATED THAT THE DEVICE SWITCHED TO AMBIENT MODE, TECHNICAL FAILURE TF 485001 (AMBIENT FAILURE DETECTED). THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. THE VENTILATOR DEVICE GOT REPLACED IN THE PRE-OPERATIONAL STAGE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503293 ↗
• MalfunctionOct 9, 2024Complete Loss of Power; Complete Loss of Power

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE FOLLOWING TECHNICAL FAILURES OCCURRED: TF444001 (BATTERY TOTALLY DISCHARGED), TF446029(AMBIENTFAILUREDETECTED), TF485001(AMBIENTFAILUREDETECTED), TF785003 (PMCHANNELOBSERVATIONFAILED). - THIS OCCURRENCE WAS NOTICED AT START-UP DURING THE BOOTING PROCESS. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405167 ↗
• MalfunctionOct 2, 2024Electrical /Electronic Property Problem; Failure to Deliver; Electrical /Electronic Property Problem; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR HAMILTON-MR1 STOPPED DURING VENTILATION. A BURNING SMELL WAS VERBALLY REPORTED BUT IS NOT CONFIRMED. THE PROVIDED LOGFILES SHOW A TECHNICAL FAILURE TF 444004. INVESTIGATION IS ONGOING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349663 ↗
• MalfunctionJul 9, 2024Insufficient Cooling; Insufficient Cooling

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: FAN FAILURE NO FURTHER INFORMATION RECEIVED. PATIENT INVOLVEMENT IS ALSO UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699294 ↗
• MalfunctionJul 9, 2024Insufficient Cooling; Defective Component; Insufficient Cooling; Defective Component

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "CUSTOMER REPORTS THAT THE VENTILATOR DEVICE DISPLAYED FAN FAILURE". THIS OCCURRENCE WAS NOTICED AT START-UP DURING THE BOOTING PROCESS. THERE IS NO PRIOR INDICATION THAT SOMETHING WAS TECHNICALLY WRONG WITH THE VENTILATOR DEVICE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. FAN GOT REPLACED. SERVICE SOFTWARE SUCCESSFULLY PERFORMED. THE VENTILATOR DEVICE PASSED ALL TESTS. UNIT RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699272 ↗
• MalfunctionJul 8, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DEVICE FAILED FOR THE TIGHTNESS TEST (LEAKAGE)". THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. THERE IS NO PRIOR INDICATION THAT SOMETHING WAS TECHNICALLY WRONG WITH THE VENTILATOR DEVICE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688326 ↗
• MalfunctionJun 20, 2024Failure to Run on Battery; Complete Loss of Power; Failure to Run on Battery; Complete Loss of Power

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING STANDBY. BATTERIES DISCHARGING WHILE IDLE ON 4/27. BATTERY LOW AND EXTERNAL POWER LOSS ALARMS. SERVICE REQUIRED, TF'S 444001, 446029, 485001, 785003 ALARMED. NO POWER OFF IN LOGS ON 4/27. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575304 ↗
• MalfunctionJan 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON WHILE THE CUSTOMER EXPERIENCED DIFFICULTIES WITH ADJUSTING THE VENTILATOR DEVICE IN A WAY (IN PCV+ MODUS) TO ENSURE THAT THE VENTILATION IS ADEQUATE. FOR SOME REASONS (EITHER DUE TO THE PATIENT'S HEALTH CONDITION OR DUE TO TRANSPORT WITHIN THE HOSPITAL TO THE MRI ROOM) THE CUSTOMER REPORTED THAT THEY SWITCHED BACK AND FORWARD BETWEEN THIS HAMILTON-MR1 (IN PCV+ MODE) AND A ICU VENTILATOR. BOTH VENTILATOR DEVICES HAD THE SAME SETTINGS. THE NEONATAL PATIENT WAS SEDATED. BLOOD PRESSURE AND HEARTBEAT OF THE NEONATAL PATIENT INCREASED RAPIDLY. THE END-TIDAL CO2 MEASURED VALUE WAS 9. FINALLY, BY USING THE HAMILTON-MR1 IN SIMV MODE, THE PATIENT'S CONDITION STABILIZED AND REMAINED STABLE THROUGHOUT THE MRI SESSION. IT WAS NOT REPORTED WHETHER ALARMS WERE TRIGGERED. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS PATIENT INVOLVEMENT REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595815 ↗
• MalfunctionJan 21, 2024Battery Problem: Low Impedance; Battery Problem: Low Impedance

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE ALARMED FOR BATTERY REPLACEMENT. BATTERY 2: MANUFACTURING DATE 22-08-2022, CYCLES 33, ERROR 2%, SOH 7.4%. IT'S REPORTED THAT THIS OCCURRENCE WAS NOT NOTICED DURING PATIENT VENTILATION. HOWEVER, THE DEVICE LOGS PROOF DIFFERENT. THE ALARM WAS VISUALLY OBSERVABLE. "BATTERY 2 REPLACEMENT REQUIRED". THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON EXCEPT OF THE TESLASPY LOGS. THE DEVICE LOG FILES DO SHOW THAT THIS ALARM FIRST APPEARED DURING VENTILATION. THIS ALARM WAS REPRODUCIBLE. THERE IS PATIENT INVOLVEMENT REPORTED. IT'S NOT REPORTED AS SUCH BUT THE DEVICE LOGS PROOF THAT THIS BATTERY ALARM FIRST APPEARED DURING VENTILATION. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18549149 ↗
• MalfunctionDec 15, 2023Gas/Air Leak; Gas/Air Leak

  TE231008 - O2-VALVE LEAK OCCURED. CANNOT REPRODUCE ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334911 ↗
• MalfunctionNov 15, 2023Improper Flow or Infusion; No Apparent Adverse Event; Improper Flow or Infusion; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THE MEASURED INSPIRATORY TIDAL VOLUME (VTI) AND THE EXPIRATORY TIDAL VOLUME (VTE) ARE HIGHER THAN THE SET TIDAL VOLUME. (VT PLUS > 50%) AND THE VENTILATOR ALARMED. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - VARIOUS ALARMS WERE OBSERVED BY THE CUSTOMER. PATIENT ALARMS: PA133002 (VOLUMELIMITREACHED), PA141017 (DISCONNECTIONPATIENT), PA141066(APVMAXIMUMLEAKCOMPENSATION), PA141004(EXPMINVOLHIGH), PA141002 (VTHIGH), PA141005(EXPMINVOLLOW), PA141003 (VTLOW). - HOWEVER, THE DEVICE LOG FILES DID NOT SHOW ANY TECHNICAL FAILURES NOR TECHNICAL EVENTS (TF/TE). - PATIENT INVOLVEMENT: THE EVENT WAS NOTICED DURING PATIENT VENTILATION. THERE IS NO INTERRUPTION OF VENTILATION REPORTED. - MEDICAL INTERVENTION: THE FAULTY VENTILATOR DEVICE WAS TAKEN OUT OF SERVICE. THERE WAS NO FURTHER INFORMATION AS TO WHETHER A REPLACEMENT DEVICE HAS BEEN USED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137600 ↗
• InjuryMay 12, 2023Device Handling Problem; Device Handling Problem

  VENTILATION STOPED WHEN BROUGHT TO CLOSE TO MRI MACHINE. UNKNOWN PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 16924494 ↗