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

Model Number 5803

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the table fell.

Event Description

Table fall was reported with patient on.Customer also stated that the t-pin was missing but table still held in place until moved patient and then it dropped.

Manufacturer Narrative

Based on the information received from incident investigation, it was determined that there were no issues with the device and user error was contributed to falling of the table top with patient on.Inservice staff training was provided following the incident.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Type of Device: 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 ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 14640383
• MDR Text Key: 294839268
• Report Number: 2921578-2022-00010
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other