MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161005
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: cer (b)(4).Confirmed fault, device also came up with 231022.Replaced pressure sensor assembly.Completed test software as per latest service manual.Device passes all checks and calibration including electrical safety test.
Event or Problem Description
The following was reported to hamilton medical ag: customer returned ventilator to hamilton medical workshop, device was unable to calibrate flow sensors.No patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Confirmed fault, device also came up with 231022.Replaced pressure sensor assembly.Completed test software as per latest service manual.Device passes all checks and calibration including electrical safety test.Follow-up 1 - corrected information: a udi-di was provided for this device brand and version (generally) in the initial report, yet hamilton medical ag (hmag) established that this particular device (serial number: (b)(6)) was not labelled with a udi at the time of its manufacturing.Creation of udi was not a requirement at the time of manufacturing of this particular device (prior to 2015) and had not yet been implemented in production at hmag.Udi data has therefore been removed in this corrected follow-up report.A full udi (including udi-pi) will not be provided, this is in alignment with the information on the label on the device with the serial number (b)(6).
Event or Problem Description
The following was reported to hamilton medical ag: customer returned ventilator to hamilton medical workshop, device was unable to calibrate flow sensors.No patient involvement.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• 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: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19070257
• Report Number: 3001421318-2024-00864
• Device Sequence Number: 4657812
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181216
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 161005
• Device Catalogue Number: 161005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 07/05/2012
• 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