AMSCO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-20 for AMSCO * manufactured by Steris Corporation.

Event Text Entries

[3667468] The or table was checked and was functional prior to beginning the case. Patient moved onto the or table and, when patient was secured to the table, it was unlocked and the table was moved into surgical position. Upon attempting to lock the table again, there appeared to be no electricity to the bed to lock it. The plug was removed and changed out with another plug, still couldn't lock the bed. The plug was then plugged into different outlets, without success. The patient had to be moved to a different or table. ======================manufacturer response for operating room surgical table, surgical table (per site reporter). ======================manufacturer response for surgical table, surgical table (per site reporter). ======================none at this time. What was the original intended procedure? Shoulder arthroscopy. Device #1is this a laboratory device or laboratory test? No. Device #2is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3250735
• MDR Report Key: 3250735
• Date Received: 2013-06-20
• Date of Report: 2013-06-20
• Date of Event: 2013-05-21
• Report Date: 2013-06-20
• Date Reported to FDA: 2013-06-20
• Date Reported to Mfgr: 2013-07-29
• Date Added to Maude: 2013-07-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AMSCO
• Generic Name: TABLE, SURGICAL
• Product Code: BWN
• Date Received: 2013-06-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STERIS CORPORATION
• Manufacturer Address: 5960 HEISLEY ROAD MENTOR OH 44060 US 44060

Device Sequence Number: 2

• Brand Name: AMSCO
• Generic Name: TABLE, SURGICAL
• Product Code: BWN
• Date Received: 2013-06-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 10
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: STERIS CORPORATION
• Manufacturer Address: 5960 HEISLEY ROAD MENTOR OH 44060 US 44060

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-20