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	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a case staff did not lock the rotation safety lock and table tilted and patient fell off.Reported patient was not hurt.Went through x rays and no injuries were reported.
Additional Manufacturer Narrative
Per information received from further investigation and device evaluation, it was found that there was no problem with the device.Hospital personnel leaned on the table which led to flipping of the foot-end switch thus unlocking the foot end and causing the patient fall.It was also learned that the rotation safety lock was not locked by the staff despite the warning mentioned in the owner's manual which say "failure to ensure that the 180 degree rotation lock and the rotation safety lock are locked with the corresponding blue indicator lights on both the head-end column and hand pendant illuminated may result in harm to the patient, healthcare workers or device" no patient injury was reported after running the diagnostic test (x-ray).
Event or Problem Description
During a case staff did not lock the rotation safety lock and table tilted and patient fell off.Reported patient was not hurt.Went through x rays and no injuries were reported.

• 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 avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587 ; 5104291500
• MDR Report Key: 15332157
• Report Number: 2921578-2022-00016
• Device Sequence Number: 17874446
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/15/2022

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: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown