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

Model Number 5803

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that the rotation lock of the surgery table was not holding which caused the table to tilt with patient on it.

Manufacturer Narrative

Based on the information received from the incident investigation, it was found out that the brake locks of the table that are supposed to hold the patient were unknowigly left released by the hospital personnel which led to the tilting of the table.

Event Description

It was reported that the rotation lock of the surgery table was not holding which caused the table to tilt with patient on it.The x-ray tech was next to the patient and noticed the table was rolling (tilting) and caught the table top and patient and gently rolled him to the floor.

• 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 14876899
• MDR Text Key: 303268357
• Report Number: 2921578-2022-00011
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2009
• 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): Other
• Patient Sex: Male