AMSCO 2080 RC/1A *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-28 for AMSCO 2080 RC/1A * manufactured by Steris Corp.

Event Text Entries

[99350] At the completion of a surgical procedure the pt went into cardiac arrest. While chest compressions were being performed when the upper segment of the or table collapsed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 184590
• MDR Report Key: 184590
• Date Received: 1998-08-28
• Date of Report: 1998-08-24
• Date of Event: 1998-08-12
• Date Facility Aware: 1998-08-12
• Report Date: 1998-08-24
• Date Reported to FDA: 1998-08-24
• Date Reported to Mfgr: 1998-08-24
• Date Added to Maude: 1998-09-01
• 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 Details

• Brand Name: AMSCO
• Generic Name: MAJOR SURGICAL TABLE
• Product Code: FSE
• Date Received: 1998-08-28
• Model Number: 2080 RC/1A
• Catalog Number: *
• Lot Number: *
• ID Number: PHONE 800-548-4875
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 179436
• Manufacturer: STERIS CORP
• Manufacturer Address: 5960 HEISLEY RD MENTOR OH 440601834 US
• Baseline Brand Name: AMSCO 2080IA SURGICAL TABLE
• Baseline Generic Name: SURGICAL TABLE
• Baseline Model No: 2080IA
• Baseline Catalog No: TC-800
• Baseline ID: BE56-727-000-02

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-08-28