MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton while the customer experienced difficulties with adjusting the ventilator device in a way (in pcv+ modus) to ensure that the ventilation is adequate.For some reasons (either due to the patient's health condition or due to transport within the hospital to the mri room) the customer reported that they switched back and forward between this hamilton-mr1 (in pcv+ mode) and a icu ventilator.Both ventilator devices had the same settings.The neonatal patient was sedated.Blood pressure and heartbeat of the neonatal patient increased rapidly.The end-tidal co2 measured value was 9.Finally, by using the hamilton-mr1 in simv mode, the patient's condition stabilized and remained stable throughout the mri session.It was not reported whether alarms were triggered.The device log files were provided to hamilton.There is patient involvement reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Follow-up 1 - corrected information: udi related data quality updates only.Field d4 was updated with full udi information. .
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton while the customer experienced difficulties with adjusting the ventilator device in a way (in pcv+ modus) to ensure that the ventilation is adequate.For some reasons (either due to the patient's health condition or due to transport within the hospital to the mri room) the customer reported that they switched back and forward between this hamilton-mr1 (in pcv+ mode) and a icu ventilator.Both ventilator devices had the same settings.The neonatal patient was sedated.Blood pressure and heartbeat of the neonatal patient increased rapidly.The end-tidal co2 measured value was 9.Finally, by using the hamilton-mr1 in simv mode, the patient's condition stabilized and remained stable throughout the mri session.It was not reported whether alarms were triggered.The device log files were provided to hamilton.There is patient involvement reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.

• Brand Name: HAMILTON-MR1
• Common Device Name: 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: 18595815
• Report Number: 3001421318-2024-00224
• Device Sequence Number: 6726222
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)220301(240)1610100
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K153046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1610100
• Device Catalogue Number: 1610100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown