MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON; HAMILTON-T1

Model Number HAMILTON-T1

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 07/09/2022

Event Type  Injury  

Event Description

Rt claims she was electrocuted/shocked when turning on machine before paitient use.They heard a loud popping and smell coming from the machine.Currently unknown date/time of occurance or exact extend of problems.Potentially same event linked to medsun report: no serial number or contact information provided in medsun report.Https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/medsun/medsun_details.Cfm?id=78986.

• Brand Name: HAMILTON
• Type of Device: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 15403008
• MDR Text Key: 299703153
• Report Number: 0002937708-2022-00009
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: 07630002806091
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

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 Operator: Health Professional
• Device Model Number: HAMILTON-T1
• Device Catalogue Number: 161009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2022
• Distributor Facility Aware Date: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention