MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number T1

Device Problems Device Emits Odor (1425); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2022

Event Type  malfunction  

Event Description

Hamilton t1 transport ventilator is kept in trauma bay.Priority called for patient with multiple gsw to chest and abdominal area.Rts prepared to intubate due to high risk, ventilator was attempted to be turned on.Screen would not turn on, machine started beeping non-stop with no ability to turn it off.Multiple rts noticed a burning smell from the machine.At this time the rts swapped to new ventilator.Equipment report placed.Biomed evaluating.

• Brand Name: HAMILTON-T1
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL AG; 4910 longley lane; suite 101; reno NV 89502
• MDR Report Key: 15102836
• MDR Text Key: 296584088
• Report Number: 15102836
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1