MAUDE Adverse Event Report: MIZUHO OSI ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number	5803
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient transferred to operation table.The head end rotation knob was locked, and the foot end column was not locked.Staff noticed some instability in the table and swung out from the patient.The patient fell to the floor.The patient was examined; received ct scans and trauma work-up with no identified physical concerns from the incident.
Additional Manufacturer Narrative
Based on the information obtained from investigation, the table did not have any functional issues.It was found the foot end column was unlocked and table had some instability.The patient swung out and fell to the floor.An in-service training was performed by mizuho osi personnel for hospital staff on proper use of the table and ensuring that both head and foot ends are locked.
Event or Problem Description
Patient transferred to operation table.The head end rotation knob was locked, and the foot end column was not locked.Staff noticed some instability in the table, attempted troubleshooting by unlocking the other end.Tabletop swung out and patient fell to the floor.The patient was examined; received ct scans and trauma work-up with no identified physical concerns from the incident.
Additional Manufacturer Narrative
The manual explains the operation of the head-end and foot-end locks and warns that user training is requred.The locks are labeled with warnings that they need to be locked prior to patient transfer.An in-service training was performed by mizuho osi personnel for hospital staff on proper use of the table and ensuring that both head and foot ends are locked.

• 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17786399
• Report Number: 2921578-2023-00015
• Device Sequence Number: 7490876
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 08/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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 Age: 5 YR
• Patient Sex: Unknown