MAUDE Adverse Event Report: MIZUHO OSI TRIOS RADIOLUCENT IMAGING TOP; OPERATING TABLE

Model Number	7927
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was prone on the table, secured with some kind of disposable strap, which broke.Patient fell off table, experiencing a contusion.
Additional Manufacturer Narrative
Following the information obtained from the investigation, no problems with the device were found.Lateral tilt function was engaged instead of intended reverse trendelenburg function that cause the table to tilt unexpectedly.A disposable safety strap was used that is not manufactured by mizuho osi and that did not hold the patient during the unexpected table tilt thus causing the patient fall.Minor skin tears and abrasion were observed in the patient following the fall.The patient was treated immediately and given discharge the same day.
Event or Problem Description
Patient was prone on the table, secured with some kind of disposable strap, which broke.Patient fell off table, experiencing a contusion.

• Brand Name: TRIOS RADIOLUCENT IMAGING TOP
• 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: 17996225
• Report Number: 2921578-2023-00019
• Device Sequence Number: 20463050
• Product Code: JEA
• UDI-Device Identifier: 00842430104213
• UDI-Public: (01)00842430104213
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: 7927
• Device Catalogue Number: 7927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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