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	Fall (1848)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient incident was reported in the middle of the case.Patient was sliding off the imaging top when the staff noticed it and before the patient fell they caught him by the feet and head and lowered the patient to the floor.No patient injury reported at this time.
Event or Problem Description
A patient incident was reported in the middle of the case.Patient was sliding off the imaging top when the staff noticed it and before the patient fell they caught him by the feet and head and lowered the patient to the floor.No patient injury reported at this time.
Additional Manufacturer Narrative
Based on the information received from the investigation and device evaluation it was found that there are no problems with the device.It is suspected that the safety belts may have been removed by hospital personnel while preparing to move the patient from operating table to a transport bed.This may have lead to an erroneous unlock of the table allowing it to swing freely thereby causing the patient to fall.It was also noted that the table did not undergo preventative maintenance check since 2019 despite being mentioned in the owner's manual that a preventative maintenance should be conducted annually or at least once a year.

• 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16976652
• Report Number: 2921578-2023-00006
• Device Sequence Number: 6499318
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/27/2023

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?: No
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• 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: Other
• Patient Sex: Male
• Patient Weight: 159 KG