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	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient fell from the table.
Event or Problem Description
It was reported that a patient fell from the table.
Additional Manufacturer Narrative
Based on the information obtained from investigation and device evaluation, there were no issues with the table.While transferring the patient from the table to transport/recovery bed, the perineal post and the holding tape were removed and patient was dropped.The patient was taken to ct scanner following the drop but no injuries were to be found.

• 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: 17300115
• Report Number: 2921578-2023-00010
• Device Sequence Number: 7064033
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/08/2023

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: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2012
• 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: Unknown