MAUDE Adverse Event Report: MIZUHO OSI TABLE, HANA, 110 V; OPERATING TABLE

Model Number 6875

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that a patient fell from the hana table right before transferring them off.The perineal post was removed and safety strap was not used during case; the patient woke up sooner than anticipated before transfer and fell.Head ct performed.Patient was reportedly not injured.

Manufacturer Narrative

Following the evaluation of the device, it was found that there were no issues with the device and it performed per product specifications.Based on the information received from the investigation, it was deemed as an user error as the hospital staff did not use safety strap during the operation and perineal post was removed while the patient was still on the table contrary to the instructions mentioned in the owner's manual.Onsite staff training was performed following the incident.

Event Description

It was reported that a patient fell from the hana table right before transferring them off.The perineal post was removed and safety strap was not used during case; the patient woke up sooner than anticipated before transfer and fell.Head ct performed.Patient was reportedly not injured.

• Brand Name: TABLE, HANA, 110 V
• Type of Device: 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 94587-1234 ; 5104291500
• MDR Report Key: 15946349
• MDR Text Key: 305145522
• Report Number: 2921578-2022-00025
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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