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

Model Number 5803

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 08/15/2022

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 299290464
• Report Number: 2921578-2022-00014
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2013
• 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
• Patient Outcome(s): Life Threatening; Required Intervention