MAUDE Adverse Event Report: MIZUHO OSI 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	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case a patient almost dropped off the table.The hospital staff went to level the table but rather than level it tilted further.The staff caught the patient.No patient injury occured.
Additional Manufacturer Narrative
The failure described in the section b5, ".Went to level the table but rather than level it tilted further." was resolved by adjusting the micro switches on the head end of the table to manufacture specification.Based on the information received from investigation, there were no records of service or preventative maintenance found for this device.Despite the verbiage in the owner's manual section 5.3 " a preventative maintenance (pm) check on this product is required at least once every year.If the device is excessively or abusively used, the manual rotation locking mechanism and foot-end locking mechanism should be regularly checked to ensure the 95 ft-lb torque is maintained", no history of preventative maintenance was found.An on-site training is scheduled to discuss and revisit the proper use, maintenance and servicing of the product.
Event or Problem Description
It was reported that during a case a patient almost dropped off the table.The hospital staff went to level the table but rather than level it tilted further.The staff caught the patient.No patient injury occured.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16709459
• Report Number: 2921578-2023-00004
• Device Sequence Number: 12281920
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: Unknown