MAUDE Adverse Event Report: STERIS SAS CMAX X-RAY SURGICAL TABLE

Model Number	Cmax X-ray Imaging Table
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the subject event is in process.Steris is awaiting a response from the customer to schedule an onsite inspection of the surgical table subject of the event.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during cleaning activities an employee attempted to connect the power cable to the cmax x-ray surgical table and they experienced an electrical shock.No report of consequence on health of the employee.During the event, the table was not in use and there was no patient involvement.
Additional Manufacturer Narrative
A steris service engineer arrived onsite to inspect the table and found that the plug of the power supply was damaged resulting in the reported event.The cmax x-ray surgical table user manual states (p10 - electrical safety): "warning risk of personal injury in case of any damage to the power supply, power cord, plug, or iec receptacle, do not connect the equipment and immediately contact steris technical support." the technician replaced the power cable, tested the table, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.

• Brand Name: CMAX X-RAY SURGICAL TABLE
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer (Section G): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15417009
• Report Number: 3011221111-2022-00001
• Device Sequence Number: 12443015
• Product Code: GDC
• UDI-Device Identifier: 00724995216825
• UDI-Public: 00724995216825
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Cmax X-ray Imaging Table
• Device Catalogue Number: ST0161000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown