IMRIS T2X OPERATING ROOM TABLE 109682-600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-09 for IMRIS T2X OPERATING ROOM TABLE 109682-600 manufactured by Imris-deerfield Imaging, Inc..

MAUDE Entry Details

• Report Number: 3010326005-2019-00010
• MDR Report Key: 8681358
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-06-09
• Date of Report: 2019-06-09
• Date of Event: 2019-05-14
• Date Mfgr Received: 2019-05-14
• Device Manufacturer Date: 2011-05-17
• Date Added to Maude: 2019-06-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. TODD SPERLING
• Manufacturer Street: 5101 SHADY OAK ROAD
• Manufacturer City: MINNETONKA MN 553434100
• Manufacturer Country: US
• Manufacturer Postal: 553434100
• Manufacturer Phone: 7632036344
• Manufacturer G1: IMRIS-DEERFIELD IMAGING, INC.
• Manufacturer Street: 5101 SHADY OAK ROAD
• Manufacturer City: MINNETONKA MN 553434100
• Manufacturer Country: US
• Manufacturer Postal Code: 553434100
• Single Use: 3
• Remedial Action: RP
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMRIS T2X OPERATING ROOM TABLE
• Generic Name: OPERATING ROOM TABLE
• Product Code: KXJ
• Date Received: 2019-06-09
• Model Number: T2X
• Catalog Number: 109682-600
• Lot Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IMRIS-DEERFIELD IMAGING, INC.
• Manufacturer Address: 5101 SHADY OAK ROAD MINNETONKA MN 553434100 US 553434100

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-09