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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

It was reported that the patient fell as he was stepping off the foot rest from a prestige vh upon completion of the exam.The result of the patient falling was minor scratches to the patients elbow and wrist that were treated with disinfectant.

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 foot rest damage from multiple impacts over a ten year period which resulted in stress in the casting and misalignment in foot rest locking which caused the foot rest to break when the patient stepped on it.Root cause is therefore inappropriate handling/usage by the user.The site was corrected by replacing the foot rest.No further actions are planned at this time.

• Brand Name: PRESTIGE VH
• 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: 4700320
• MDR Text Key: 5720114
• Report Number: 2126677-2015-00006
• 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
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

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: Not provided
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 89 YR
• Patient Weight: 55