MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE SI; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that when the table of a prestige si was tilted to 90 degrees and the patient was standing on the foot rest, the right side handle of the foot rest gave way and fell down to the floor.The patient didn't fall and there was no patient injured as a result of this event.

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Ge healthcare's investigation is completed, the root cause was determined to be use error since the foot rest showed signs of damage caused by impact.This damage caused deformation of the locking handles which then affected the locking effectiveness.The site was corrected by replacing the foot rest.No further actions are planned at this time.

• Brand Name: PRESTIGE SI
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer Contact: paul corrigan ; 3000 n.grandview blvd.; w450; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4769023
• MDR Text Key: 5788139
• Report Number: 2126677-2015-00009
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/1990
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 120