MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON; HAMILTON-G5

Model Number 159001

Device Problems Connection Problem (2900); Failure to Shut Off (2939)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2021

Event Type  Injury  

Event Description

During ventilation, panel connection lost.Ventilation stopped.User was unable to turn ventilator off.

Event Description

During ventilation, panel connection lost.Ventilation stopped.User was unable to turn ventilator off.

Manufacturer Narrative

Included udi in report.

• Brand Name: HAMILTON
• Type of Device: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 11211342
• MDR Text Key: 228161538
• Report Number: 0002937708-2021-00006
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: 07630002800013
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2021,08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 159001
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2021
• Distributor Facility Aware Date: 01/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention