MAUDE Adverse Event Report: MIZUHO CORPORATION SKYTRON; 6500HD ELITE HERCULES HEAVY DUTY

Model Number T02-6500-HD

Device Problems Device Slipped (1584); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2017

Event Type  malfunction  

Event Description

This is a resubmission of mdr 1825014-2018-00003.Original mdr was not submitted correctly.This is in response to medwatch (b)(4) submitted by (b)(6) hospital.The medwatch states that the patient was in reverse trendelenburg on surgery table, the patient began to slide off of operating table.Bed would not work, unable to straighten.Procedure stopped and steril ioban dressing applied.Patient moved from original operating room bed to another operating room bed.Complete new operating room set up opened.Surgical procedure resumed.No patient injuries reported.Skytron will reach out to their the local distributor in the area, ten medical to visit the facility and evaluate the table.

• Brand Name: SKYTRON
• Type of Device: 6500HD ELITE HERCULES HEAVY DUTY
• Manufacturer (Section D): MIZUHO CORPORATION; 2-27-17 hongo; bunkyo-ku tokyo, japan 113, JA; JA 113, JA
• MDR Report Key: 7303168
• MDR Text Key: 217688914
• Report Number: 1825014-2018-00003
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: T02-6500-HD
• Device Catalogue Number: T02-6500-HD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Distributor Facility Aware Date: 01/30/2018
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic