MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).The investigation is ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "black screen and a high-pitched alarm".This occurrence was noticed at start-up during the booting process.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.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).The investigation is ongoing.Hamilton medical ag complaint number: cer (b)(4).Follow-up 1 - device evaluation: root cause: service tests were performed on the affected ventilator, yet the described issue could not be reproduced.This issue would not be visible in the log files.The root cause could not be confirmed.Most likely, the failing startup process was caused by device initialization difficulties due to a slow start because of an older esm revision or due to a ram initialization problem.If a start-up fails in such a manner, the ventilator can be made operable by restarting it.After successful testing, the ventilator was returned to use.No patient involvement was reported in the described incident.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "black screen and a high-pitched alarm".- this occurrence was noticed at start-up during the booting process.- 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.

• 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: konstantin deilhof ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20480701
• Report Number: 3001421318-2024-02508
• Device Sequence Number: 8267290
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)190712(240)161010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 161010
• Device Catalogue Number: 161010
• Device Lot Number: NOT APPLICABLE
• 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: 10/05/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 07/12/2019
• 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