AMACO 3080 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-10 for AMACO 3080 * manufactured by Amsco -steris-.

Event Text Entries

[17430538] Or table lowered by hand control to meet height of cart. Pt transferred onto or table. Table on its own went into reverse trendelenburg. A motor was heard while this happened. Table position could be corrected with controls on table pedestal, but not responsive to hand controls commands. Pt was removed from table and a new table was brought into room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026143
• MDR Report Key: 416337
• Date Received: 2002-09-10
• Date of Report: 2002-09-10
• Date of Event: 2002-08-29
• Date Added to Maude: 2002-09-16
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMACO
• Generic Name: OR TABLE
• Product Code: FSE
• Date Received: 2002-09-10
• Model Number: 3080
• Catalog Number: *
• Lot Number: BE587283
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 405373
• Manufacturer: AMSCO -STERIS-
• Manufacturer Address: * * *
• Baseline Brand Name: AMSCO 3080
• Baseline Generic Name: OR TABLE
• Baseline Model No: 3080
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-09-10