MAUDE Adverse Event Report: MIZUHO OSI ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number	5803
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the table top fell wth a patient on during surgery.The reporter indicated that the issue occured with the pin at the h-frame of the table.Patient coded 20 minutes later but the reporter was not sure if this was due to the drop of because of the surgery.
Additional Manufacturer Narrative
The device was evaluated by the field service engineer and no issues were found with the functioning of the device.Based on the information received from the investigation, it was found that the t-pin was not completely engaged to secure and lock the h-frame which led to the falling of the table top during the surgery.We believe this was an user error as there are instructions in the owner's manual regarding locking the t-pin and warning(s) that state the following- "failure to install the t-pin properly through one side of the h-frame completely through the table top mounting tune and then through the opposite side of the h-frame with the drop lock visible and pivoting freely may result in harm to the patient, healthcare worker or the device" the details of the patient and their health status were not disclosed by the hospital personnel.
Event or Problem Description
It was reported that the table top fell wth a patient on during surgery.The reporter indicated that the issue occured with the t-pin at the h-frame of the table.Patient coded 20 minutes later but the reporter was not sure if this was due to the drop of because of the surgery.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15245982
• Report Number: 2921578-2022-00014
• Device Sequence Number: 17594500
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2013
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown