MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Codes	Failure to Power Up (1476); Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag event reference number: cer (b)(4).The internal product investigation is still ongoing.As soon as the results are available, the manufacturer will submit an update of this report unsolicited.
Event or Problem Description
The event description according to the customer is as follows: ventilator lost all options.Can't select mode.
Additional Manufacturer Narrative
Hamilton medical ag event reference number: (b)(4).The internal product investigation is still ongoing.As soon as the results are available, the manufacturer will submit an update of this report unsolicited.Hamilton medical ag complaint number: (b)(4).Follow-up 1 - device repaired: root cause: defect esm board.Measures taken: esm board replaced and options re-entered.The ventilator device passed all tests successfully and got put back in service.Updated fields: b4, d4, e1, e2, e3, g1, g4, g6, h2, h6, h7, h11.
Event or Problem Description
The event description according to the customer is as follows: ventilator lost all options.Can't select mode.

• 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 MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20367178
• Report Number: 3001421318-2024-02376
• Device Sequence Number: 3890277
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)150522(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 161010
• Device Catalogue Number: 161010
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2015
• 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