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

Model Number 7927

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

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)

Event Date 10/13/2023

Event Type  Injury  

Event Description

Patient was prone on the table, secured with some kind of disposable strap, which broke.Patient fell off table, experiencing a contusion.

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 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
• 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: 17996225
• MDR Text Key: 326388381
• Report Number: 2921578-2023-00019
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104213
• UDI-Public: (01)00842430104213
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7927
• Device Catalogue Number: 7927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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