SKYTRON 3502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-21 for SKYTRON 3502 manufactured by Mizuho.

Event Text Entries

[19973453] The pt wa reversed on the table and the pt's weight was not evenly distributed. This lead to the table tipping and required the hospital staff to catch the pt to prevent injury to the pt. Hospital staff recognized improper use was the contributing factor to the incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825014-2014-00015
• MDR Report Key: 4210250
• Date Received: 2014-10-21
• Date of Report: 2014-10-16
• Date of Event: 2014-10-01
• Date Facility Aware: 2014-10-01
• Report Date: 2014-10-16
• Date Reported to FDA: 2014-10-17
• Date Reported to Mfgr: 2014-10-17
• Date Added to Maude: 2014-10-30
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 5000 36TH ST., S.E.
• Manufacturer City: GRAND RAPIDS MI 49512
• Manufacturer Country: US
• Manufacturer Postal: 49512
• Manufacturer G1: SKYTRON, DIV. THE KMW GROUP, INC.
• Manufacturer Street: 5000 36TH ST., S.E.
• Manufacturer City: GRAND RAPIDS MI 49512
• Manufacturer Country: US
• Manufacturer Postal Code: 49512
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SKYTRON
• Generic Name: SURGICAL TABLE
• Product Code: BWN
• Date Received: 2014-10-21
• Model Number: 3502
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO
• Manufacturer Address: TOKYO JA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-10-21