MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS, TABLE BASE; SURGICAL OPERATING TABLE

Model Number	7803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported tabletop started tilting at the end of the procedure, luckily the nurse caught the patient before he/she fell.
Additional Manufacturer Narrative
Upon completing a preventative maintenance the only issue found were loose bolts that mount the head-end column to the base of the trios table, which is not related to the table tilted on its own.If the table tilted at all, it would have to have the foot-end brake physically release by the staff, otherwise the table tilt will not occur.This lead to potential operator error, indicating that someone on the staff physical released the 180 degree handle on the head-section assembly.When you release the 180 degree handle, both amber lights will blink, which indicates that brake is release.
Event or Problem Description
It was reported tabletop started tilting at the end of the procedure, luckily the nurse caught the patient before he/she fell.

• Brand Name: TRIOS, TABLE BASE
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11377827
• Report Number: 2921578-2021-00006
• Device Sequence Number: 3781607
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: 00842430103957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1