OPERON B810 B810 075-1003 048

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-13 for OPERON B810 B810 075-1003 048 manufactured by Berchtold Corporation.

Event Text Entries

[15027717] During a routine adjustment of the or operating room table using the regular pendant the table malfunctioned and the head end continued to lower. The patient ended up with their head down near the floor and staff had to keep pt from slipping off the table. The table was in such an orientation that the manual foot pump and pendant in the base could not be accessed. After a few minutes the table was leveled using the regular pendant and stools were placed under the head end to prevent a recurrence. The case was finished without further incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 561422
• MDR Report Key: 561422
• Date Received: 2004-01-13
• Date of Report: 2004-01-13
• Date of Event: 2003-12-15
• Report Date: 2004-01-13
• Date Reported to FDA: 2004-01-13
• Date Added to Maude: 2004-12-28
• 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
• 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: OPERON B810
• Generic Name: OPERATING TABLE
• Product Code: FSE
• Date Received: 2004-01-13
• Model Number: OPERON B810
• Catalog Number: B810 075-1003 048
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Device Age: 6 MOS.
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 551131
• Manufacturer: BERCHTOLD CORPORATION
• Manufacturer Address: 1950 HANAHAN ROAD CHARLESTON SC 29406 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-01-13