HAMILTON-T1 1610090Recalls & reported problems

Summary

The FDA's MAUDE database contains 368 adverse event reports that list this exact device (DI 07630002813549), received between Sep 15, 2022 and Mar 10, 2025 — classified as 3 deaths, 8 injuries, 357 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (128 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-2527-2023 · Root cause: Nonconforming Material/Component · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 368 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DEVICE VISUALLY ALARMING WTH TECHNICAL EVENT 231008". NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558373 ↗
• MalfunctionJul 16, 2024Insufficient Flow or Under Infusion; No Flow; Insufficient Flow or Under Infusion; No Flow

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: THE PATIENT HAD A SPORTS ACCIDENT. PROBLEM-FREE VENTILATION IN THE AMBULANCE. THE PATIENT WAS THEN TRANSFERRED TO THE RESCUE HELICOPTER, WHERE ALARMS WERE RAISED ABOUT INSUFFICIENT OXYGEN SUPPLY AND NO VOLUMES/FLOW COULD BE MEASURED. ONLY THE PRESSURE CURVE SHOWED VALUES. THE PATIENT'S THORAX WAS NO LONGER RISING. AFTER RESTARTING THE HAMILTON-T1 VENTILATOR THE SITUATION DID NOT IMPROVE. THE PATIENT WAS VENTILATED BY USING AN AMBU-BAG. THEREAFTER THE PATIENT WAS FURTHER VENTILATED BY USING A DIFFERENT VENTILATOR DEVICE. - PLEASE NOTE THAT THERE WAS NO HARM TO THE PATIENT REPORTED DUE TO THE USE AND MALFUNCTION OF THE DEVICE. THE PATIENT WAS FURTHER SUPPORTED FIRST THROUGH VENTILATION OVER AN AMBU-BAG AND THEN A DIFFERENT DEVICE WAS USED. THE TRANSPORTATION OF THE PATIENT TILL THE HOSPITAL WAS POSSIBLE AND THE PATIENT WAS SUPPORTED WITH THE ALTERNATIVE DEVICE. THE INVESTIGATION IS STILL ONGOING.

  Patient problems: Insufficient Information; Respiratory Insufficiency

  MAUDE report 19749348 ↗
• MalfunctionJul 16, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: INTERMITTENTLY FAILS THE TIGHTNESS CHECK. FLOW PASSES THROUGH THE CIRCUIT & DIPHRAM COVER, OUT THE EXHALATION PORT OF THE COVER. FAILED SERVICE SOFTWARE TESTS: PROX TESTS: PROXIMAL PRESSURE & PROXIMAL FLOW. OCCURRED DURING A TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748568 ↗
• MalfunctionJul 5, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING SERVICE, UNABLE TO CALIBRATE PRESSURE, DOES NOT HOLD PRESSURE AND EXPELS IT THROUGH THE EXPIRATORY VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678074 ↗
• MalfunctionJul 5, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: DURING SERVICE, UNABLE TO CALIBRATE PRESSURE, DOES NOT HOLD PRESSURE AND EXPELS IT THROUGH THE EXPIRATORY VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678057 ↗
• MalfunctionJul 5, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING SERVICE, UNABLE TO CALIBRATE PRESSURE, DOES NOT HOLD PRESSURE AND EXPELS IT THROUGH THE EXPIRATORY VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678015 ↗
• MalfunctionJul 5, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: UNABLE TO CALIBRATE PRESSURE, DOES NOT HOLD PRESSURE AND EXPELS IT THROUGH THE EXPIRATORY VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677983 ↗
• MalfunctionJul 5, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: DURING SERVICE, UNABLE TO CALIBRATE PRESSURE, DOES NOT HOLD PRESSURE AND EXPELS IT THROUGH THE EXPIRATORY VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677980 ↗
• MalfunctionJun 25, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BLOWER FLOW TEST FAILED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604043 ↗
• MalfunctionMay 8, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: VENT WILL NOT PASS PRE-USE CHECK - WILL NOT BUILD PRESSURE. TECH SUPPORT TALKED BIOMED THROUGH TESTING THE UNIT AND FOUND THAT THE EXPIRATORY ASSEMBLY IS NOT FUNCTIONING PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267813 ↗
• MalfunctionApr 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE PATIENT WAS BROUGHT INTO THE HOSPITAL BECAUSE HE/SHE WAS SUFFERING FROM AN OUT OF HOSPITAL CARDIAC ARREST. THE PATIENT WAS STABLE AND NEEDED TO BE TRANSPORTED TO THE CT. DURING PREPARATION OR BEFORE STARTING TRANSPORT, THE HAMILTON-T1 VENTILATOR DID NOT PROVIDED THE SET TIDALVOLUME OF 480 ML AND THE TIDALVOLUME DROPPED TO 130 ML WHICH RESULTED IN AN SPO2 DROP TO 80%. HCP WAS AT THE BEDSIDE AND IMMEDIATELY STARTED VENTILATING THE PATIENT BY USING A MANUAL RESUSCITATOR (AMBU BAG). THE SPO2 RECOVERED TO 100%. THE SPO2-DROP WAS TOO SHORT TO CAUSE ANY HARM. THEREFORE, THE HOSPITAL DID NOT REPORT ANY PATIENT HARM. FINALLY, ANOTHER MECHANICAL VENTILATOR DEVICE GOT CONNECTED TO THE PATIENT AND THE SCHEDULED COMPUTED TOMOGRAPHY (CT) TREATMENT CONTINUED. ONLY THE DEVICE EVENT-LOG WAS PROVIDED. HAMILTON MEDICAL AG DID NOT RECEIVE THE SERVICE-LOG AND THE ERROR-LOG. WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED TO HAMILTON MEDICAL AG. THE INVESTIGATION IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211219 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE FAILED FOR THE TIGHTNESS TEST AND THE FLOW SENSOR CALIBRATION. THIS WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. A VISUAL ALARM WAS OBSERVABLE (MESSAGE ALERT). TIGHTNESS TEST FAILURE. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. THIS MALFUNCTIONING WAS REPRODUCIBLE. 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 STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152923 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Insufficient Device Problem Information; Gas/Air Leak; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE FAILED FOR THE TIGHTNESS TEST. - 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. THE REPORTED INFORMATION IS VERY POOR AND FOR THE SAKE OF CERTAINLY WE ASSUME THAT THIS EVENT OCCURRED DURING THE PRE-OPERATIONAL CHECK WHAT MAKES THIS CASE REPORTABLE. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (ERROR CODES / MESSAGE ALERTS) AND THROUGH HEARING. NO FURTHER DETAILS ABOUT THE ALARMS 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 STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150476 ↗
• MalfunctionApr 13, 2024Failure to Run on Battery; Battery Problem; Failure to Run on Battery; Battery Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: VENTILATION OF A PATIENT IN THE REGA JET. WHEN THE PATIENT WAS TRANSFERRED, THE T1 SWITCHED OFF WITHOUT ANYONE HAVING TO DO ANYTHING. SEE MOVIE 1 PATIENT WAS VENTILATED MANUALLY. WHEN THE CREW RETURNED, THE T1 ALERTED WITH A WHITE SCREEN AND ACTIVE VENTILATION. THE DEVICE WAS VERY WARM. USER WANTED TO SWITCH OFF THE T1, BUT DID NOT KNOW THAT HE HAD TO PRESS THE SWITCH FOR 30 SECONDS. THE RESPI WAS THEN LEFT WITH A BATTERY. ACCORDING TO THE USER, IT STARTED UP AGAIN AUTOMATICALLY AFTER APPROX. 1 HOUR. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102622 ↗
• MalfunctionApr 11, 2024Complete Loss of Power; Complete Loss of Power

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: POWER PLUG WAS NOT FUNCTION WHEN PLUGGED IN. TRIED 2 OTHER PLUGS AND NO POWER. THIS WAS DURING PM. OPEN THE DEVICE AND CHECK THE VOLTAGES AND WAS GETTING NOTHING. ALSO THE FRONT DISPLAY COVER WAS CRACKED. WILL BE REPLACING THAT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085809 ↗
• MalfunctionApr 9, 2024Failure to Calibrate; Failure to Calibrate

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: CUSTOMER RETURNED VENTILATOR TO HAMILTON MEDICAL WORKSHOP, DEVICE WAS UNABLE TO CALIBRATE FLOW SENSORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070257 ↗
• MalfunctionMar 18, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED. THIS OCCURRENCE WAS NOTICED WHEN THE VENTILATOR DEVICE WAS IN STANDBY MODE AND HAS NOT BEEN FURTHER EXPLAINED NOR CLARIFIED. A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (ERROR CODE) AND THROUGH HEARING. TE231008 (O2 VALVE LEAK). THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON. THIS MALFUNCTIONING WAS REPRODUCIBLE. 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 18922633 ↗
• MalfunctionMar 12, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: RELEASE VALVE DEFECTIVE. NO PATIENT HARM OR CONSEQUENCES REPORTED. UNKNOWN IF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18883902 ↗
• InjuryMar 5, 2024Improper 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: - THIS EVENT WAS REPORTED TO HAMILTON AS, VENTILATOR DEVICE STOPPED FUNCTIONING. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON. NO TECHNICAL ERROR OR TECHNICAL EVENT CAN BE SEEN IN THE LOG FILE. - THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING PATIENT VENTILATION. - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. TO PREVENT THE ALARM FROM CONTINUING, THE DEVICE WAS TURNED OFF BY REMOVING THE AC POWER AND BATTERY. THEN THE VENTILATOR WAS TURNED ON AGAIN. BY A MISTAKE MADE BY THE HOSPITAL STAFF THE VENTILATOR DEVICE REMAINED IN STANDBY MODE. DURING THAT TIME, THE PATIENT WAS NOT VENTILATED BY THE VENTILATOR DEVICE. - NEITHER DELAY IN TREATMENT NOR HARM TO THE USER OR THIRD PARTY HAS BEEN REPORTED. HOWEVER PATIENT HARM WAS REPORTED, BUT HAMILTON RECEIVED NO FURTHER DETAILS REGARDING THE PATIENT HARM. THE INVESTIGATION IS STILL ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 18836469 ↗
• InjuryFeb 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER STATES:-WE HAD A CLINICAL INCIDENT AWHILE AGO (16TH SEPTEMBER) INVOLVING A T1 IN ICU AND IT HAS ONLY JUST BEEN HIGHLIGHTED TO MEDICAL EQUIPMENT MANAGEMENT, HENCE THE DELAY IN REPORTING. EXCERPT OF THE INCIDENT INVOLVING A NEONATE IS AS FOLLOWS: CHILD WITH PROBABLE PNEUMOMEDIASTINUM DEVELOPED RESPIRATORY FAILURE REQUIRING INTUBATION AND VENTILATION. DIFFICULT TO VENTILATE, BUT HAMILTON T1 TRANSPORT VENTILATOR UNABLE TO VENTILATE WITHOUT SIGNIFICANT REBREATHING OF CO2. AT THE TIME THE CHILD'S FICO2 WAS 5-6KPA, AND PACO2 WAS IN EXCESS OF 16KPA WITH PH OF < 7.0. TWO CONSULTANT INTENSIVISTS WERE WITH THE CHID. THE HAMITON T1 BROUGHT BY THE WATCH TEAM HAD SIMILAR PROBLEMS BUT TO A SLIGHTLY LESSER EXTENT. THE CHILD VENTILATED REASONABLY WELL ON THE ICU BEDSIDE MAQET SERVO I VENTILATOR. VENTILATION STILL PROBLEMATIC WHEN THE CHILD LEFT THE RDE FOR BCH.

  Patient problems: Insufficient Information

  MAUDE report 18719962 ↗
• InjuryFeb 16, 2024Intermittent Loss of Power; Intermittent Loss of Power

  THE T1 SWITCHED OFF SUDDENLY WHILE TRANSFERRING PATIENT FROM ICU TO ANOTHER WARD, THE PATIENT NEARLY DIE. PATIENT WAS USING THE T1 FROM SEVERAL DAYS BEFORE TO 21-OCT. TIME OF INCIDENCE WAS AROUND 12:00 NOON 21-OCT. ACCORDING TO NURSES, 15 MINUTES AFTER TRANSPORT, THE T1 SUDDENLY SWITCHED OFF. NURSES CHECKED WHETHER BATTERY WAS SECURELY ATTACHED TO T1, AND ALSO PLUG AND UNPLUG. THEREFORE IN THE EVENT LOG IT SHOWS THE BATTERY CONNECT AND DISCONNECT. AFTER THAT THEY CONTINUE USING, AND THE T1 TURNED OFF SEVERAL TIMES DURING TRANSPORT (NOT ONLY ONE TIME).

  Patient problems: Insufficient Information

  MAUDE report 18719953 ↗
• MalfunctionFeb 15, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TIGHTNESS & FLOW SENSOR TESTS OF THE PREOP CHECKS DO NOT PASS NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711369 ↗
• MalfunctionFeb 14, 2024Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON AS, VENTILATOR DEVICE FAILED AT START-UP DURING THE BOOTING PROCESS AND ALARMED. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TF281002 (TASTU_JTAG NOT WORKING). - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON. - 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 CUSTOMER ADDRESS HAMILTON RECEIVED WITH A DELAY ON DATE 13-FEB-24. (B)(6). THE INVESTIGATION IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701291 ↗
• InjuryDec 28, 2023Pressure Problem; Pressure Problem

  PSA NOTES: MECHANICAL VENTILATOR EXPIRATORY VALVE MALFUNCTION. RESPIRATORY RATE NOT MEASURING CORRECTLY. MULTIPLE ATTEMPTS TO RECALIBRATE AND USED DIFFERENT CIRCUIT AS WELL WHILE RECALIBRATING. PT HAD TO BE HAND BAGGED VENTILATED WITH FLOW INFLATING BAG DURING WHOLE TRANSPORT TO (B)(6) PICU.

  Patient problems: Insufficient Information

  MAUDE report 18414024 ↗
• MalfunctionDec 18, 2023Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE FAILED FOR TIGHTNESS TEST AND ALARMED. THE TIGHTNESS TEST IS STANDARD PART OF THE PREOPERATIONAL 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. BASED ON THE AVAILABLE INFORMATION, FOR THIS REPORTED INCIDENT THE FIRST APPLIES, NAMELY DURING PREOPERATIONAL CHECK. THE CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 241002 (TIGHTNESS TEST RELEASE VALVE DEFECT). THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. 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 STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344219 ↗