MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Battery Problem: Low Impedance (2973)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
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 as ventilator device alarmed for battery replacement.Battery 2: manufacturing date 22-08-2022, cycles 33, error 2%, soh 7.4%.It's reported that this occurrence was not noticed during patient ventilation.However, the device logs proof different.The alarm was visually observable."battery 2 replacement required".The device log files were provided to hamilton except of the teslaspy logs.The device log files do show that this alarm first appeared during ventilation.This alarm was reproducible.There is patient involvement reported.It's not reported as such but the device logs proof that this battery alarm first appeared during ventilation.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 complaint number: cer (b)(4).Initial report: the initial report was originally submitted on date 21-jan-2024.For some unknown reason hamilton medical ag never received an acknowledgement notice.Hamilton medical ag complaint number: cer (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 as ventilator device alarmed for battery replacement.Battery 2: manufacturing date 22-08-2022, cycles 33, error 2%, soh 7.4%.It's reported that this occurrence was not noticed during patient ventilation.However, the device logs proof different.The alarm was visually observable."battery 2 replacement required".The device log files were provided to hamilton except of the teslaspy logs.The device log files do show that this alarm first appeared during ventilation.This alarm was reproducible.There is patient involvement reported.It's not reported as such but the device logs proof that this this battery alarm first appeared during ventilation.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.
Event or Problem Description
The following was reported to hamilton medical ag: - this event was reported to hamilton as ventilator device alarmed for battery replacement.Battery 2: manufacturing date 22-08-2022, cycles 33, error 2%, soh 7.4%.- it's reported that this occurrence was not noticed during patient ventilation.However, the device logs proof different.- the alarm was visually observable."battery 2 replacement required".- the device log files were provided to hamilton except of the teslaspy logs.The device log files do show that this alarm first appeared during ventilation.- this alarm was reproducible.- there is patient involvement reported.It's not reported as such but the device logs proof that this this battery alarm first appeared during ventilation.- 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 complaint number: (b)(4).Initial report: the initial report was originally submitted on date 21-jan-2024.For some unknown reason hamilton medical ag never received an acknowledgement notice.Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: udi related data quality updates only.Field d4 was updated with full udi information.Updated fields: b4, d1, d3, d4, g4, g6, h2, h4, h11.Follow-up 2 - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.It was reported that the device was alarming "battery 2 replacement required during ventilation of a patient.No harm reported.The event did not cause or contribute to a death or serious injury to a patient.The root cause of the event was determined to be a defective battery.After replacing the battery, the device passed the service software tests and the device was released back into use.

• 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: 18549149
• Report Number: 3001421318-2024-00162
• Device Sequence Number: 7923111
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)230124(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/10/2025

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: 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: 12/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 12/21/2023
• Initial Report FDA Received Date: 01/21/2024
• Supplement Report FDA Received Date: 11/12/2024; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2023
• 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