* 308S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-27 for * 308S manufactured by Amsco/steris.

Event Text Entries

[16821689] The pt was being raised on the o. R. Table when upper sheet metal shroud stuck under the lower shroud causing the base at the table to lift. The staff were concerned the table was unsafe to continue surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022717
• MDR Report Key: 349455
• Date Received: 2001-08-27
• Date of Report: 2001-08-27
• Date of Event: 2001-08-22
• Date Added to Maude: 2001-09-04
• 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: *
• Generic Name: OR TABLE
• Product Code: FSE
• Date Received: 2001-08-27
• Model Number: 308S
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 338755
• Manufacturer: AMSCO/STERIS
• Manufacturer Address: 5960 HEISLEY RD MENTOR OH 44060 US
• Baseline Brand Name: *
• Baseline Generic Name: OR TABLE
• Baseline Model No: 308S
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-08-27