MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-MR1

Model Number HAMILTON-MR1

Device Problem Gas Output Problem (1266)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  Death  

Manufacturer Narrative

Hamilton medical ag case number is (b)(4).Investigation ongoing.

Event Description

The following was reported to hamilton medical ag: - this event with date of (b)(6) 2024 (exact time was not provided) has been assessed as reportable.The patient died while being ventilated with a hamilton-mr1 ventilator device.Please note that the hamilton-mr1 ventilator is used for mri examination.The exact context of the death was not indicated (during or prior the mri).It is indicated that the ventilator device gave a low oxygen alarm.The setting of ventilator was mainly at a 100% fio2 setting in pcv+ mode.- the device log files (service log, error log, event log) were provided to hamilton medical ag except of the teslaspy log file and the technical state of the device.The available log files show that: 'low oxygen' and 'oxygen supply failed' alarms were observed along other patient alarms throughout the available event logs of ventilation when it was used the last time before the date of incident.Device alarmed for 'low oxygen' at 100% fio2 setting during ventilation in pcv+ mode.The ventilation was started on reported date of incident at 23:04:37 in apvcmv mode and later it was switched to pcv+ mode.The device was finally switched to standby at 23:11:29 the same day (note: standby was set up by medical personal).- there is need for medical intervention reported.This intervention is not further specified nor explained.- neither delay in treatment nor harm to user or third party has been reported.However patient harm is reported as the patient passed away during the use of the ventilator.- measures taken: the hospital tried to reproduce the situation after the event.No technical failures were found in the provided logfile.The ventilator device passed the pre-operational check successfully.The investigation is ongoing.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDIAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18940104
• MDR Text Key: 338123949
• Report Number: 3001421318-2024-00545
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-MR1
• Device Catalogue Number: 161010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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): Death