MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-C1

Model Number HAMILTON-C1

Device Problem Failure to Power Up (1476)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag case number is: (b)(4).

Event Description

The following was reported to hamilton medical ag: c1 s/n (b)(6) powered on with a dark screen in the rt department, but would not properly bootup.Watchdog alarm sounded, but alarm lamp did not work and soft keys were dim.Failure occurred during power on in rt department.No patient involved.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18737190
• MDR Text Key: 336770296
• Report Number: 3001421318-2024-00414
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-C1
• Device Catalogue Number: 161001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1