MAUDE Adverse Event Report: HAMILTON MEDCIAL AG HAMILTON-C1

Model Number HAMILTON-C1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2024

Event Type  Injury  

Event Description

Customer alerted account manager telling them that ventilation stopped on (b)(6) 2024.Ow battery alarms ignored by user.Ventilation stops (ambient mode).In event log: battery low alarms.Tf 444001 (batteries completely discharged).Tf 485001 ambient mode.

• Brand Name: HAMILTON-C1
• Type of Device: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDCIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18930459
• MDR Text Key: 338004732
• Report Number: 3016723884-2024-00005
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HAMILTON-C1
• Device Catalogue Number: 161001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2024
• Distributor Facility Aware Date: 02/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other