HAMILTON-MR1 161010Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 07630002800761), received between Jan 21, 2021 and May 4, 2026 — classified as 3 deaths, 127 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (19 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-2530-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Activation Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG: "WHEN THE USER ON THE UNIT, "TESLASPY SERVICE REQUIRED" ALARM IS SHOWN". IT WAS REPORTED NO PATIENT INVOLVEMENT. NO HARM TO ANY PATIENT, USER OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067194 ↗
• MalfunctionApr 14, 2026No Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG: ¿FAN FAILURE ALARM BASED ON INFORMATION PROVIDED BY THE HOSPITAL¿S BIOMEDICAL DEPARTMENT, THE DEVICE APPEARS TO HAVE BEEN BROUGHT TOO CLOSE TO THE MRI MAGNETIC FIELD.¿ IT WAS REPORTED THAT NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT OCCURRED. THE DEVICE REMOVED FROM PATIENT AND SENT TO HAMILTON FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877643 ↗
• MalfunctionMar 26, 2026Improper Flow or Infusion

  IT WAS REPORTED TO HAMILTON MEDICAL AG: "EXHALATION OBSTRUCTED, INSPIRATORY VOL. ALARMS. LOW PRESSURE PEEP PROBLEMS, LOW VT, HIGH FREQUENCY". 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 24696443 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: ¿IMMEDIATELY AFTER STARTING VENTILATION, MR1 DISPLAYS THE ERROR MESSAGES ¿EXPIRATORY STENOSIS¿ AND ¿PEEP TOO HIGH.¿ A PATIENT WAS CONNECTED AND DEVICE WAS EXCHANGED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415040 ↗
• MalfunctionOct 29, 2025Computer Software Problem; Computer Software Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE LOCAL STAFF WAS CONDUCTING AN OPERATIONAL CHECK OF MR1. WHEN THE POWER TO MR1 WAS TURNED ON, IT SUDDENLY SWITCHED TO SAFETY MODE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411114 ↗
• MalfunctionAug 20, 2025Gas Output Problem; Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE ALARMED WITH LOW OXYGEN. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847839 ↗
• MalfunctionAug 20, 2025Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: QUOTATION FROM THE REPORTER: "THE BLOWER MADULE IS NOT ENERGIZING DURING POST AND THE MR1 KEEPS ALARMING SAYING THE BLOWER IS NOT FUNCTIONING." NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847490 ↗
• MalfunctionMay 23, 2025Insufficient Cooling; Insufficient Cooling

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "FAN FAILURE ALARM". THERE IS PATIENT INVOLVEMENT REPORTED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. 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. THERE WE ASSESSED THIS EVENT AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076589 ↗
• MalfunctionApr 30, 2025Defective Component; Defective Component

  DURING PATIENT VENTILATION THE HAMILTON-MR1 VENTILATOR DEVICE ALERTED FOR FAN FAILURE. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NO DEVICE LOG FILES WERE PROVIDED TO HAMILTON MEDICAL. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932705 ↗
• MalfunctionApr 23, 2025Insufficient Cooling; Insufficient Cooling

  ¿HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "VENT BEGAN ALARMING FAN FAILURE". THERE IS NO PATIENT INVOLVEMENT. THE DEVICE LOG FILES WHERE NOT PROVIDED TO HAMILTON MEDICAL. IN A WORST-CASE SCENARIO, A FAN FAILURE COULD LEAD TO A DETERIORATION OF THE STATE OF HEALTH OF THE PATIENT. THEREFORE, THIS CASE WAS ASSESSED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889374 ↗
• MalfunctionMar 5, 2025Complete Loss of Power; Complete Loss of Power

  THE (B)(6) DID SUBMIT TO BFARM THE REPORT WITH REFERENCE (B)(4). HAMILTON MEDICAL ENTER THE CASE UNDER THE REFERENCE (B)(4). HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION ¿THE DEVICE SWITCHED ITSELF OFF COMPLETELY. THE LOG FILES SHOW THAT THE DEVICE RAN ON BATTERY POWER UNTIL IT SWITCHED ITSELF OFF¿. THE FIRST ANALYSIS OF THE LOGFILE AS PROVIDED BY THE LOCAL PARTNER SHOWS THAT ALARMS WERE IGNORED. ALARMS SUCH AS ¿LOSS OF EXTERNAL POWER¿ AND ¿BATTERY LOW WARNINGS¿ WERE IGNORED FROM THE MOMENT THAT THE DEVICE WAS STARTED UP ON REPORTED DAY (B)(6) 2025. DEVICE STARTED AT 14:50:49 AND THE DEVICE REPORTED A LOSS OF EXTERNAL POWER AT 14:51:00. AT 14:51:01, THE DEVICE REPORTED A HIGH-PRIORITY BATTERY LOW ALARM, WHICH WAS RESET AT 14:51:03. THE DEVICE REPEATEDLY ALERTED WITH BATTERY LOW UNTIL IT SWITCHED TO AMBIENT STATUS AT 15:36:50 AND SHUT ITSELF OFF AT 16:53:43. THE EXACT TIME OF THE MRI EXAMINATION OF THE AFFECTED PATIENT IS UNKNOWN. THE OPERATOR MANUAL FOR THE HAMILTON-MR1 CLEARLY STATES THAT THE DEVICE SHOULD BE CONNECTED TO THE PRIMARY POWER SOURCE. THE BATTERIES ARE FOR BACKUP. ALSO, THE BATTERIES LEVELS NEED TO BE CHECKED BEFORE USAGES. STARTING WITH A FLAT BATT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523867 ↗
• MalfunctionFeb 26, 2025Gas Output Problem; Gas Output Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE VENTILATOR DEVICE ALERTS FOR LOW O2. IN USER MODE THE O2 SET VALUE COULD NOT BE REACHED OR IT TAKES TO LONG BEFORE REACHING IT. THERE IS PATIENT INVOLVEMENT REPORTED BUT IS NOT FURTHER SPECIFIED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. WORST CASE, A LOW O2 FLOW COULD LEAD TO SEVERE DESATURATION (SPO2 <80%).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468124 ↗
• MalfunctionFeb 18, 2025Gas/Air Leak; Gas/Air Leak

  DURING PREVENTIVE MAINTENANCE THE VENTILATOR DEVICE FAILED FOR THE O2 MIXER TEST. THE LOG FILES ARE NOT AVAILABLE TO CONFIRM THIS. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. WORST CASE THIS ISSUE COULD LEAD TO HYPEROXEMIA (SPO2 >98%) WHAT MAKES THIS CASE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399697 ↗
• MalfunctionFeb 6, 2025Computer Operating System Problem; Insufficient Device Problem Information; Computer Operating System Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: START-UP FAILED (BLACK SCREEN) AND THE VENTILATOR DEVICE ALARMED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322084 ↗
• MalfunctionFeb 6, 2025Failure of Device to Self-Test; Operating System Becomes Nonfunctional; Failure of Device to Self-Test; Operating System Becomes Nonfunctional

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DEVICE FAILED AT START-UP AND ALARMED CONTINUOUSLY. USER HAD TO LONG PRESS THE POWER BUTTON TO POWER DOWN THE DEVICE". THERE IS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320198 ↗
• MalfunctionJan 9, 2025Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "TIGHTNESS TEST FAILED AND SHOW ALARM MESSAGE RELEASE VALVE DEFECTIVE". - THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. - 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. - MEASURES TAKEN: REPLACED THE CHECK VALVE ASSEMBLY (PN MSP161193), PERFORMED THE SERVICE SOFTWARE AND VENTILATOR PUT BACK IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110440 ↗
• MalfunctionJan 9, 2025Infusion or Flow Problem; Unexpected Shutdown; Infusion or Flow Problem; Unexpected Shutdown

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DISPLAY SHOWED FAN FAILURE". THE LOG FILES SHOWED THAT THE DEVICE STOPPED DURING PATIENT VENTILATION AND AT NEXT START-UP THE VENTILATOR ALARMED FOR FAN FAILURE. 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 21109414 ↗
• MalfunctionDec 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: BABY WAS ON NASAL CPAP AND BABY HAD DESATURATION TO 50%. NO FURTHER INFORMATION RECEIVED. THERE WAS NO INFORMATION ABOUT A MALFUNCTION OF THE DEVICE. NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046384 ↗
• MalfunctionDec 31, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING ROUTINE MAINTENANCE, TECHNICAL FAULTS 431002, 446024, 44004 (VOLTAGE OUT OF TOLERANCE) OCCURRED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046127 ↗
• MalfunctionDec 5, 2024Gas Output Problem; Gas Output Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION FROM THE THIRD-PARTY BIOMEDICAL TECHNOLOGY SERVICES COMPANY, "'THE UNIT CAME IN DUE TO MULTIPLE LOW OXYGEN ALARMS DURING VENTILATION.". THIS OCCURRENCE WAS NOTICED DURING PATIENT 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. MEASURES TAKEN: REPLACED THE O2 MIXER ASSEMBLY (PN MSP161619), PERFORMED THE SERVICE SOFTWARE SUCCESSFULLY, VENTILATOR DEVICE PUT BACK IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852427 ↗
• MalfunctionNov 26, 2024Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DEVICE COMPLETE SHUT DOWN AND COULD NOT BE SWITCHED ON AGAIN. BOTH BATTERIES WERE FULLY CHARGED". - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. PATIENT WAS VENTILATED BY USING A MANUAL RESUSCITATOR (AMBU BAG). - NO HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785952 ↗
• MalfunctionNov 14, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "TIGHTNESS CHECK FAILED. OBSTRUCTION VALVE CLOSE PRESSURE TOO LOW: 40.5 MBAR (MIN: 43.0 MBAR) VISUAL INSPECTION OF OBSTR. VALVE APPEARS TO BE OUT OF PLACE". - IT'S NOT REPORTED TO HAMILTON MEDICAL AG WHEN EXACTLY THE TIGHTNESS TEST FAILED. THE TIGHTNESS TEST IS STANDARD PART OF THE PRE-OPERATIONAL CHECK AND GETS PERFORMED WHEN THE BREATHING CIRCUIT IS REPLACED. THE TIGHTNESS TEST IS ALSO PART OF THE SERVICE SOFTWARE WHAT GETS PERFORMED DURING MAINTENANCE. SINCE THIS WAS NOT REPORTED WE MUST ASSUME THAT IT HAPPENED DURING THE PRE-OPERATIONAL CHECK WHAT MAKES THIS EVENT REPORTABLE. · 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 20680694 ↗
• MalfunctionOct 30, 2024Insufficient Cooling; Insufficient Cooling

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION FROM A THIRD-PARTY SERVICE COMPANY NAMED ATLANTIC RESPIRATORY SERVICES INC: "THE CUSTOMER COMPLAINT OF FAN FAILURE. ATLANTIC RESPIRATORY SERVICES INC. TROUBLESHOT THE ISSUE AND WAS ABLE TO DUPLICATE ISSUES, FOUND FAN INTERMITTENTLY STOPPED WORKING AND UNIT WOULD THROW FAN FAILURE ALARM". 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 20564906 ↗
• MalfunctionOct 18, 2024No Display/Image; Failure to Power Up; Activation, Positioning or Separation Problem; Activation Failure; No Display/Image; Failure to Power Up; Activation, Positioning or Separation Problem; Activation Failure

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "BLACK SCREEN AND A HIGH-PITCHED ALARM". THIS OCCURRENCE WAS NOTICED AT START-UP DURING THE BOOTING PROCESS. 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 20480701 ↗
• MalfunctionOct 4, 2024Failure to Power Up; Computer Operating System Problem; Failure to Power Up; Computer Operating System Problem

  THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: VENTILATOR LOST ALL OPTIONS. CAN'T SELECT MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367178 ↗