MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number	5803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was on or bed, and bed unexpectedly moved, left side tilted down.Staff was able to prevent the patient from falling, no harm to patient.
Additional Manufacturer Narrative
Per the information obtained from device evaluation, it was found out that the table had one loose caster, dc power connectivity problems and slight rust observed on the center beam.These issues were fixed by mizuho osi service engineer.The reason for the table tilt remains unclear as there was no evidence found that indicated any issue with the tilt mechanism of the table.It was also found out that the device was last serviced by mizuho osi in 2019 and was currently being subjected to service and maintenance process by a third party (non-mizuho osi) establishment.There is also no evidence that indicates the frequency of maintenance by the user.The root cause for this incident is thus deemed as lack of preventive maintenance by the user.
Event or Problem Description
Patient was on or bed, and bed unexpectedly moved, left side tilted down.Staff was able to prevent the patient from falling, no harm to patient.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94887-1234 ; 5104291500
• MDR Report Key: 19919952
• Report Number: 2921578-2024-00012
• Device Sequence Number: 8104165
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 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: 07/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2008
• 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
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White