MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5; HAMILTON-G5 VENTILATOR

Catalog Number 159001

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag has formed a task force with a team of experts to conduct a full investigation with high priority.Updates will be provided.Potential measures such as interviews, products investigations (list not exhaustive) are being evaluated.

Event Description

Hamilton medical ag received the following incident description by the local partner on 01.03.2024: : on (b)(6) 2024 at the (b)(6) in the aro department, around 14:00, the hamilton g5 ventilator s/n : (b)(6) spontaneously combusted.The event occurred during ventilation of the patient.This patient was ventilated on ventilator g5 s/n : (b)(6) for the fourth day without interruption.According to the information of the staff standing nearby, the hissing of a gas leak inside the ventilator was suddenly heard and an immediate ignition occurred.Due to the fire, the entire department had to be evacuated including the patients.No one was injured during the incident, only a few staff members inhaled smoke.The hamilton g5 lung ventilator s/n (b)(6) was installed on the department in 2014 other than this replacement, the fan has never had a malfunction or any other repair.The last inspection and preventive maintenance was performed on (b)(6) 2023.According to the conclusion of the investigation of the firefighters, apparently due to material fatigue, there was a sudden leakage of oxygen in the vicinity of the oxygen mixer valve and subsequently , probably due to static charge, an ignition.At the moment we don´t have ofitial report.Further information was then submitted by sukl with the date of (b)(6) 2024: combustion of the lung ventilator.A pulmonary ventilator fire occurred during pulmonary ventilation.The lung ventilator had been running for several days according to the testimony of the nursing staff present with the patient, the ventilator was first an audible hissing sound was first heard and then the machine started.The staff present performed a disconnection the pacinette and initiated its evacuation.At the same time, he disconnected the machine from the medical gas lines and initiated extinguishing the apparatus with a powder extinguisher.The apparatus was subsequently extinguished by another technical personnel, who arrived at the scene of the fire after the fire alarm was triggered.According to the firefighters, the cause of the fire was an oxygen leak from a solenoid valve located behind the entrance to the of the apparatus.The ignition could have been caused by dirt or by oxygen flowing at high speed to an inappropriate part of the fan.The cause was not battery ignition or an electrical short circuit.The cause was clearly a technical fault and other causes (unprofessional handling, etc.) were excluded.The report from the fire brigade is not yet available.In addition to the patient on pulmonary ventilation, 6 other patients were evacuated from the ward and a medical staff.Subsequently, the entire floor (approximately 100 people) was evacuated due to smoke.One staff member ended up in hospital after inhalation, 2 others in treatment on the spot.In addition to the burnt ventilator itself (total destruction), there are about 400 other pieces of equipment contaminated with soot and fire extinguishing agents.

Event Description

Update of the incident description: hamilton medical ag received the following incident description on (b)(6) 2024: on (b)(6) 2024 at the (b)(6) department, around 2 pm, the hamilton g5 ventilator s/n : (b)(6) spontaneously combusted.The event occurred during ventilation of the patient.This patient was ventilated on the same ventilator g5 s/n : (b)(6) for the fourth day without interruption.According to the information of the hospital staff standing nearby, the hissing of a gas leak inside the ventilator was suddenly heard and an immediate ignition occurred.Hamilton medical is currently closely working with the hospital, local partner and respective competent authority on this matter.As per today, the root cause is still unclear.All previous claims about a possible cause have so far not been confirmed.Investigations by an independent expert are ongoing to analyze the exact root cause of the incident.The investigation is in agreement with the respective competent authority.Hamilton medical will provide the information as soon as possible.

Manufacturer Narrative

The affected device is being investigated by an external expert.

• Brand Name: HAMILTON-G5
• Type of Device: HAMILTON-G5 VENTILATOR
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18844204
• MDR Text Key: 336956983
• Report Number: 3001421318-2024-00516
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: 07630002800013
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K193228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention