MAUDE Adverse Event Report: HAMILTON MEDCIAL AG HAMILTON-T1

Model Number	HAMILTON-T1
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Psa notes: mechanical ventilator expiratory valve malfunction.Respiratory rate not measuring correctly.Multiple attempts to recalibrate and used different circuit as well while recalibrating.Pt had to be hand bagged ventilated with flow inflating bag during whole transport to (b)(6) picu.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDCIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18414024
• Report Number: 3016723884-2023-00029
• Device Sequence Number: 8897243
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2023
• Report Date (Section F): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: HAMILTON-T1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2023
• Event Location: Other
• Date Report to Manufacturer: 12/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/27/2023