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

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi not required.Legal manufacturer: (b)(4).Ge healthcare's investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On 13-mar-2020, the customer at (b)(6) reported that during a patient exam using their prestige si system, the footrest detached from the table.There was no patient injury.

Manufacturer Narrative

Fields a1 through a4: due to country specific privacy laws, patient information could not be obtained.Correction to field b4: on 12-june-2020, the customer provided an updated event description and confirmed that the footrest was unsteady but never detached from the table railing.The customer added the patient became unsteady but did not fall and was not injured.Ge healthcare's investigation of the unsteady footrest has been completed and the cause of the event was determined to be a hardware failure.The ge field engineer (fe) arrived at the customer site to investigate the footrest and identified the screws that attach the locking handle to the foot board were loose.There are also pins on the locking handles that will lock the footrest onto the table railing.Loose locking handle screws can cause the locking handles to become inclined with respect to the board (the actual orientation of the handles should be perpendicular to the board).The changed orientation of the pins lead to an improper locking of the footrest with the mounting holes in the tabletop railing which lead to this unsteady footrest condition.Although it was investigated, it could not be determined how the locking handle fixing screws became loose.The fe recommended the footrest be replaced but the customer refused this recommendation.To fix the footrest, the fe applied loctite and tightened the locking handle screws.No further actions are needed.

• Brand Name: PRESTIGE SI ANALOGIC
• Type of Device: SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10130206
• MDR Text Key: 194779175
• Report Number: 2126677-2020-00004
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1