MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MODULAR TABLE ADVANCED CONTROL "I" BASE

Model Number 5803

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Swelling (2091)

Event Date 08/08/2013

Event Type  malfunction  

Event Description

Post-operatively, the patient fell to the floor during attempted transfer.The hospital has stated that the patient suffered swelling/bump on their head, negative results were noted.The healthcare staff noted the two blue lamps indicated the table was locked were lit just before the intubated patient fell to the floor.

Manufacturer Narrative

The hospital is aware they allowed the table to be used by personnel that had not been trained.The hospital has initiated means to ensure their failure is not repeated.

• Brand Name: MODULAR TABLE ADVANCED CONTROL "I" BASE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave.; union city CA 94587 123
• Manufacturer Contact: kirke jayne ; 30031 ahern ave.; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 3834638
• MDR Text Key: 21879482
• Report Number: 2921578-2014-00002
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/13/2014

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
• Device Operator: Other
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Other Device ID Number: MFG DATE 08/18/2006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90