MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE SI; PRESTIGE REMOTE R & F SYSTEM

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare investigation has been initiated and is ongoing.A follow-up report will be submitted once the investigation has been completed.Due to country specific privacy laws, patient information was not provided by the user.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2017, the technologist at (b)(6) in (b)(6) reported that as they were angulating the table on their prestige si fluoroscopy system during a patient exam, the foot rest detached from the table railing and the patient fell on their back.There was no injury to the patient as a result of the foot rest detaching from the table.

Manufacturer Narrative

The ge field engineer (fe) visited the site for troubleshooting and found the foot rest was detached from the table railings and lying on the floor with both foot rest locks in the unlocked position.The fe inspected the foot rest and verified the locks were functioning correctly and confirmed there was no damage to the foot rest.The foot rest was installed back on the system and the system was turned over for clinical use.Ge healthcare¿s investigation has been completed and the cause of the foot rest detaching from the table railing was due to the user not installing the foot rest to the table railing correctly.The user was reminded to check and verify the locking mechanism before each use.No further actions are needed.

• Brand Name: PRESTIGE SI
• Type of Device: PRESTIGE REMOTE R & F SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI
• Manufacturer Contact: anne krueger ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6879721
• MDR Text Key: 87865778
• Report Number: 2126677-2017-00012
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1