OPTITOP 3345209X1953 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-17 for OPTITOP 3345209X1953 * manufactured by Siemens Medical Solutions Usa, Inc..

Event Text Entries

[2167786] The patient was leaning on the table that was locked. The unit power was removed and the table free-floated when power is removed which caused the patient to fall. We asked the manufacturer if there was a retrofit to have the table lock/brake if you lose power to the table. They stated "there was not a retrofit. " we have a total of 4 rooms like this at our facility.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2218609
• MDR Report Key: 2218609
• Date Received: 2011-08-17
• Date of Report: 2011-07-27
• Date of Event: 2011-07-16
• Report Date: 2011-07-27
• Date Reported to FDA: 2011-08-17
• Date Added to Maude: 2011-08-22
• 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: OPTITOP
• Generic Name: X-RAY SYSTEM
• Product Code: IZO
• Date Received: 2011-08-17
• Model Number: 3345209X1953
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 12 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Address: 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US 19355

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-08-17