MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE

Model Number 6875

Device Problems Device Slipped (1584); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Fall (1848)

Event Date 10/12/2019

Event Type  malfunction  

Event Description

It was reported that a patient fell off the operating table.

Manufacturer Narrative

Field service inspected the table to check if there were any contributing defects, and none were found.Staff members forgot to lock the casters, and they lost their grip on patient.Arrangements were made for a refresher in-service training with staff.No information was provided regarding any patient injury.

Event Description

It was reported that a patient fell off the operating table.

• Brand Name: HANA
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 9252126
• MDR Text Key: 183888116
• Report Number: 2921578-2019-00039
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other