HAMILTON-C1 1610010Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 07630002813426), received between Sep 2, 2022 and Sep 28, 2026 — classified as 3 deaths, 6 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (22 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-2525-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Audible Alarm; No Apparent Adverse Event

  Hamilton Medial AG received the following complaint description (summary):It was reported that, on (b)(6) 2026, a HAMILTON-C1 (Product No. 1610010, S/N (b)(6), SW 3.1.1) "did not audibly alarm while alarm condition existed on patient." Patient involvement was reported. No patient, user, or third-party harm and no medical intervention were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913717 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  RT was called to bedside due to nursing stating that ventilator was spontaneously shutting off. RT came to bedside and nursing stated it happened while suctioning. RT suctioned patient and all flow from the ventilator stopped completely and patient O2 saturations dropped to low 80's and required support from AMBU bag to improve saturations. RT replaced flow sensor and exhalation valve and still the machine shut off all flow after suctioning despite the patient spontaneously breathing.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50182653 ↗
• InjuryAug 7, 2026Insufficient Device Problem Information

  While switching oxygen from tank to wall, alarm appeared "No oxygen " or "oxygen supply failed ". Duplicated the event in department and noticed that it took some time for the C1 to alarm that the vent had no oxygen. Once the O2 hose was plugged back in, the vent took some time to stop alarming "no oxygen. " It seems to reset itself because the alarm disappears. Unsure if this is normal with C1's but it did result in both patients desatting. Another event happened when vent was turned on, immediately received an alarm for "oxygen supply failed ". I switched the quick connect and that seemed to fix the issue. I took that same quick connect to the department to trial it on another unit but did not receive the same issue.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50182648 ↗
• MalfunctionJul 1, 2026Improper Flow or Infusion

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE HAMILTON-C1 VENTILATOR WAS ¿NOT GIVING FULL BREATHS¿ DURING PATIENT VENTILATION, ONLY 50¿60 ML AIR DELIVERED, NO LEAK FOUND, AND "HIGH RESPIRATORY RATE" ALARM WAS TRIGGERED. NO PATIENT, USER OR THIRD PARTY HARM NOR MEDICAL INTERVENTION WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676704 ↗
• MalfunctionMay 21, 2026Application Program Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT THE DEVICE SHUTDOWN DURING VENTILATION AND ALARMED WITH TF 385002 (SAFETY FAILURE DETECTED), TF 485001 (AMBIENT FAILURE DETECTED), TF 443001 (WATCHDOG FAILED LLS). NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240038 ↗
• MalfunctionMay 5, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE WAS REPORTED TO SHUT OFF DURING VENTILATION. PRIOR TO THE SHUTDOWN, TECHNICAL FAULTS TF 385002, 346041, 346054, AND 346040 WERE RECORDED. VENTILATION WAS CONTINUED USING AN ALTERNATIVE HAMILTON-C1. NO HARM TO THE PATIENT WAS REPORTED. THE LOGFILES WERE NOT RECEIVED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078882 ↗
• MalfunctionApr 2, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "NO FLOW WAS DELIVERED DURING HIGH FLOW VENTILATION." NO ALARMS WERE RAISED AND DEVICE "ACTED AS IF RUNNING NORMALLY." PATIENT WAS SWITCHED TO ANOTHER VENTILATOR. NO HARM TO THE PATIENT WAS REPORTED. CURRENTLY, THE INCIDENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762170 ↗
• InjuryApr 1, 2026Insufficient Device Problem Information

  DEVICE GOES TO STANDBY MODE WHILE IT WAS CONNECTED TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24760661 ↗
• MalfunctionApr 1, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "NO DELIVERY OF GASES DURING HIGH FLOW O2 THERAPY. MEASURED GAS DELIVERY DISPLAYED ON SCREEN READS BETWEEN 0.0 LPM AND 0.3LPM. DEVICE DOES NOT ALARM OR INDICATE THAT THERE IS ISSUE WITH GAS DELIVERY." - NO HEALTH CONSEQUENCES OR IMPACT - NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755176 ↗
• InjuryMar 30, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED BY THE USER OF THE DEVICE THAT THE "DEVICE WENT INTO STANDBY MODE WITHOUT INTERACTION FROM STAFF." IT WAS FURTHER REPORTED THAT A CODE BLUE WAS INITIATED FOR THE PATIENT AND THAT THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. INVESTIGATION IS ONGOING TO VERIFY THE ALLEGATIONS MADE IN THIS COMPLAINT (AS STANDBY MODUS IS NORMALLY THE RESULT OF 2 HUMAN INTERACTIONS WITH THE DEVICE). ADDITIONALLY, THE CASE WAS REPORTED BY THE USER TO THE COMPETENT AUTHORITY (FDA). THE REFERENCE NUMBER PROVIDED IS (B)(4).

  Patient problems: Respiratory Arrest

  MAUDE report 24725382 ↗
• MalfunctionFeb 25, 2026Failure to Run on Battery

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "AFTER INSTALLING NEW BATTERY S/N (B)(6) AND CHARGING AT LEAST 50%, VENT WAS ATTEMPTED TO BE USED ON A PATIENT. PRIOR TO THAT IT WAS ON BATTERY POWER AND PRODUCED TF CODES 446029, 431001, AND 485001.". IT WAS ADDITIONALLY MENTIONED THAT A DIFFERENT VENTILATOR HAD TO BE OBTAINED. NO HEATH CONSEQUENCE OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439277 ↗
• MalfunctionFeb 19, 2026Obstruction of Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH EXHALATION OBSTRUCTED DURING VENTILATION. PATIENT WAS TRANSFERRED TO A DIFFERENT HAMILTON-C1. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386996 ↗
• MalfunctionFeb 13, 2026Imprecision; Decrease in Pressure

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "LOSS OF PEEP CODED APPEARED. I CHECKED ALL CONNECTIONS, EVERYTHING WAS OKAY THE MASK HAD MINIMAL LEAK AT 7%. THEN MULTIPLE ERROR CODES APPEARED REALLY FAST AND THE UNIT SWITCHED TO CMV MODE ON ITS OWN AND WOULD NOT SWITCH BACK TO NIV ST" NO HEALTH CONSEQUENCES OR IMPACT. HOWEVER, BECAUSE THE RESPIRATORY TECHNICIAN WAS UNABLE TO CHANGE THE MODE, THEY REMOVED THIS UNIT FROM SERVICE. 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 24330223 ↗
• DeathFeb 6, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "I AM WRITING THIS LETTER IN MY CAPACITY AS THE TREATING CLINICIAN TO FORMALLY SEEK A TECHNICAL EXPLANATION AND DEVICE EVALUATION REGARDING AN ADVERSE NEONATAL OUTCOME OBSERVED WHILE USING THE HAMILTON C1 NEO VENTILATOR IN OUR NICU. PATIENT & CLINICAL CONTEXT. PATIENT: MALE NEONATE, 2 DAYS OLD. CLINICAL SETTING: NICU. VENTILATOR USED: HAMILTON C1 NEO (NEONATAL MODE). INDICATION: RESPIRATORY DISTRESS WITH METABOLIC ACIDOSIS AND HYPOXEMIA. OBJECTIVE ABG EVIDENCE: DESPITE BEING ON INVASIVE MECHANICAL VENTILATION, SERIAL ABG REPORTS REVEALED PROGRESSIVE HYPOXEMIA AND WORSENING METABOLIC ACIDOSIS, AS DETAILED BELOW: EVENING ABG ((B)(6) 2025, 06:36 PM): PH: 7.202, PAO2: 24.8 MMHG, O2 SATURATION: 34.3%, HCO3¿: 13.6 MMOL/L, BASE EXCESS: ¿14.4 MEQ/L, ANION GAP: 26.5 MMOL/L. EARLIER ABG (SAME DAY): PH: 7.310, PAO2: 64.6 MMHG, HCO3¿: 15.8 MMOL/L, BASE EXCESS: ¿10.5 MMOL/L, O2 SATURATION: 91.1%. THESE REPORTS CLEARLY INDICATE PERSISTENT AND WORSENING HYPOXEMIA WHILE ON VENTILATOR SUPPORT, DESPITE STANDARD ESCALATION OF RESPIRATORY MANAGEMENT. CRITICAL CLINICAL OBSERVATION: A NOTABLE AND CONCERNING OBSERVATION WAS THAT: WHEN THE NEON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 24275984 ↗
• MalfunctionFeb 4, 2026Application Program Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "AS PER THE END USER, VENTILATOR HAS SHUT DOWN ITSELF WITH CONTINUOUS AUDIBLE ALARMS. AFTER THE END USER TURNED ON THE DEVICE, ALARMS STOPPED. THERE WERE TECHNICAL FAULTS. TF 346040, TF 346054, TF 346041, TF385002." IT WAS MARKED IN THE COMPLAINT THAT NO PATIENT WAS INVOLVED. 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 24257594 ↗
• MalfunctionFeb 4, 2026No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: NO FLOW DELIVERED NO ALARMS RAISED DEVICE ACTED AS IF RUNNING NORMALLY. NO PATIENT INVOLVEMENT. 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 24255958 ↗
• MalfunctionFeb 3, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: WHEN THIS C1 VENTILATOR WAS BEING USED ON THE PATIENT IN PCV+ MODE, AN ALARM SUDDENLY SOUNDED, AND THE SCREEN DISPLAYED TE246015, 485001, 433001, AND 446029, AFTER WHICH THE VENTILATION OPERATION STOPPED. VENTILATOR HAD TO BE REPLACED. HOWEVER, THERE WAS NO HARM TO THE PATIENT. 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 24243707 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "CUSTOMER CALLED ABOUT THEIR HAMILTON C1 SN (B)(6) WHICH WAS ON A PATIENT. VENT HAD LOW MINUTE VOLUME AND LOW VOLUME ALARMS. VENT WAS AUTOCYCLING AND ALSO NOT DISPLAYING RESP. RATES OR VOLUME." VENTILATOR WAS EXCHANGED. 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 24176004 ↗
• MalfunctionJan 21, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION:" WHILE USING THIS C1 ON A PATIENT, AN ALARM SUDDENLY SOUNDED, DISPLAYING ¿BLOWER FAILURE,¿ AND THE VENTILATOR SWITCHED TO AMBIENT MODE. THEREFORE, THE HOSPITAL STAFF IMMEDIATELY REPLACED THE VENTILATOR." 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 24127968 ↗
• MalfunctionJan 14, 2026Defective Component

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "ERRROR 431002 BLOWER FAUILTY FOUND AT THE TIME OF CALIBATION PROCEES, SELF TEST FAILED". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065347 ↗
• MalfunctionJan 13, 2026Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "WHILE USING THIS C1 ON A PATIENT, AN ALARM SUDDENLY SOUNDED AND ¿SAFETY VENTILATION¿ WAS DISPLAYED, SO THE HOSPITAL STAFF REPLACED THE VENTILATOR." THERE WERE 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 24050693 ↗
• MalfunctionJan 6, 2026Unexpected Mode Switch

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "THE INCIDENT HAPPENED ON THE 16TH, HERE IS THE STATEMENT FROM THE RT. PLACED PT ON C1 (9074) FOR BIPAP, INITIAL EVERYTHING WAS OKAY, THEN IT SHOWED A LOSS OF PEEP ERROR, SO I CHECKED ALL CONNECTIONS, EVERYTHING WAS SECURE, THERE WAS MINIMAL LEAK ON THE MASK AT 7%, THEN THE C1 SHOWED DIFFERENT ERROR CODES AND SWITCHED INTO CMV ON ITS OWN, I TRIED TO SWITCH IT BACK TO NIV-ST BUT IT WOULD GO RIGHT BACK INTO CMV ON ITS OWN, I SWITCHED OUT MACHINE ON PATIENT FOR A NEW ONE." NO HEALTH CONSEQUENCES OR IMPACT - REPLACED HAMILTON-C1. 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 23972324 ↗
• MalfunctionNov 26, 2025Image Display Error/Artifact; Image Display Error/Artifact

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "CALL RECEIVED FROM CUSTOMER. DURING VENTILATION PARAMATERS ARE NOT SHOWING PROPERLY ON SCREEN. REPLACED VENTILATOR. LOG FILES UNABLE TO TAKE ON SUCH CONDITION. 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 23654247 ↗
• MalfunctionNov 26, 2025Pressure Problem; Pressure Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "LOSS OF PEEP, HIGH BREATH RATE. MOVED PATIENT TO ANOTHER VENTILATOR. VENTILATOR SERVICED BY ONSITE BIOMED ON 10-02-2025. ACCOUNT MANAGER COMPLETED FUNCTIONAL TESTING 11/17 WITH NO ISSUES." 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 23654165 ↗
• MalfunctionNov 4, 2025Overheating of Device; Overheating of Device

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DRIVER BOARD EMITTED SMOKE THROUGH THE BATTERY PORTS WHEN POWERED ON. CUSTOMER WANTS FULL EVAL." NO PATIENT INVOLVEMENT. 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 23462040 ↗