MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Gas/Air Leak (2946); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
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 medical ag as, ventilator device failed for the tightness test.- the tightness test is standard part of the pre-operational check and gets performed when the breathing circuit is replaced.The tightness test is also part of the service software what gets performed during maintenance.The reported information is very poor and for the sake of certainly we assume that this event occurred during the pre-operational check what makes this case reportable.- a continuous alarm was observable both visually (error codes / message alerts) and through hearing.No further details about the alarms were reported to hamilton medical ag.- 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 still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** 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: 3349) 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).Updated fields: b4, d1, d4, g6, h2, h4, h11.
Event or Problem Description
The following was reported to hamilton medical ag: - this event was reported to hamilton medical ag as, ventilator device failed for the tightness test.- the tightness test is standard part of the pre-operational check and gets performed when the breathing circuit is replaced.The tightness test is also part of the service software what gets performed during maintenance.The reported information is very poor and for the sake of certainly we assume that this event occurred during the pre-operational check what makes this case reportable.- a continuous alarm was observable both visually (error codes / message alerts) and through hearing.No further details about the alarms were reported to hamilton medical ag.- 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 still ongoing.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, ; SZ
• 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: 19150476
• Report Number: 3001421318-2024-00972
• Device Sequence Number: 9420790
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 161006
• Device Catalogue Number: 161006
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 11/25/2014
• 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