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

Model Number 11608B

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Ge healthcares 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 (b)(6) 2020, as the ge field engineer (fe) was performing servicing on a prestige vh remote fluoroscopy system, and as the fe stood up from a sitting position, their head struck the bottom of the overhead tube suspension (ots) column resulting in a laceration that was treated by applying staples.This is considered a serious injury.

Manufacturer Narrative

Ge healthcares investigation has been completed and the cause of the injury to the ge field engineer (fe) was due to a servicing error.The fe should always ensure their work area is clear of obstacles before starting any service actions.The overhead tube suspension can be moved around the exam room through ceiling railings and should have been moved off to the side at the start of servicing.In addition, the fe should always first observe the area he is about to move before they move into that area.As a correction for this incident, retraining was made with the fe reminding them to ensure their working area is clear of obstacles.The prestige 2 system was checked and no problems were found.No further actions are needed.

• Brand Name: PRESTIGE VH
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10988230
• MDR Text Key: 220893062
• Report Number: 2126677-2020-00011
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11608B
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 90