HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-02 for HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR * manufactured by Hausted Patient Handling Systems, Llc.

Event Text Entries

[20736655] Performing video swallow on small adult, the fluoroscopy arm moved too low and the obstruction alarm sounded, and control to move the fluoroscopy stopped (safety switch). However, patient's legs were trapped under the equipment. Chair could not be lowered to free patient. In review, there was a safety switch on the main console and on the remote to allow the fluoro arm to be moved up, but staff were not aware at the time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2240747
• MDR Report Key: 2240747
• Date Received: 2011-09-02
• Date of Report: 2011-09-02
• Date of Event: 2011-07-13
• Report Date: 2011-09-02
• Date Reported to FDA: 2011-09-02
• Date Added to Maude: 2011-09-09
• 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 Sequence Number: 1

• Brand Name: HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR
• Generic Name: CHAIR, IMAGING, VIDEOFLUOROSCOPIC
• Product Code: FZK
• Date Received: 2011-09-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 4 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HAUSTED PATIENT HANDLING SYSTEMS, LLC
• Manufacturer Address: 2511 MIDPARK RAOD MONTGOMERY AL 36109 US 36109

Device Sequence Number: 2

• Brand Name: MULTIDIAGNOST 4
• Generic Name: X-RAY SYSTEM, RAD/FLUORO
• Product Code: JAA
• Date Received: 2011-09-02
• Model Number: MULTIDIAGNOST 4
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
• Manufacturer Address: 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-09-02