MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TABLE, HANA, 110 V; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 6875

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

Prior to the surgery the hanna table was set up by the nurse.The table functions were checked by the surgeon and the nurse.The table was found to be fully functional and ready for surgery.In the middle of the case the table started to act up.The femur lift failed then the height control stopped working.The usual troubleshooting maneuvers failed.Biomedical technician was called and got it to work well enough to finish the case.No harm to patient.

Event Description

Prior to the surgery the hana table was set up by the nurse.The table functions were checked by the surgeon and the nurse.The table was found to be fully functional and ready for surgery.In the middle of the case the table started to act up.The femur lift failed then the height control stopped working.The usual troubleshooting maneuvers failed.Biomedical technician was called and got it to work well enough to finish the case.No harm to patient.

• Brand Name: TABLE, HANA, 110 V
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8771335
• MDR Text Key: 150443321
• Report Number: 8771335
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA