ATOMIC OR TABLE 056450 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-30 for ATOMIC OR TABLE 056450 * manufactured by *.

Event Text Entries

[727555] At the end of the urology case, just prior to moving the pt onto a stretcher, the cysto bed started to lower at the foot end toward the floor. Staff was able to move pt without incident to the stretcher. The cysto bed was not able to operate normally, so it was removed from or and tagged for repair. Diagnosis: cysto cases.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5003627
• MDR Report Key: 908324
• Date Received: 2007-08-30
• Date of Report: 2007-08-30
• Date of Event: 2007-08-23
• Date Added to Maude: 2007-09-19
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ATOMIC OR TABLE
• Generic Name: CYSTO BED
• Product Code: EYH
• Date Received: 2007-08-30
• Model Number: 056450
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 887538
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-08-30