MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC LEGACY/LEGACY-D TABLE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number 46-262751G7

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Contusion (1787)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare has initiated a root cause investigation which is ongoing.A follow-up report will be submitted when the investigation has completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2020, the technologist at (b)(6) medical center in the united states reported that while they were positioning the collimator on their ge legacy fluoroscopy system downward and out of the way preparing to shut the room down in order for a hospital maintenance representative to access the hospitals breaker panel, the collimator detached from the overhead tube suspension (ots).When the collimator detached, it fell into the technologists hands thereby slowing the speed of the collimator until it reached the table.As the collimator impacted the table, the technologists distal end of their right hand middle finger was between the collimator handle and the tabletop resulting in a minor bruise.An x-ray was taken which was negative.

Manufacturer Narrative

Ge healthcareâs investigation has been completed and the root cause of the collimator detaching was due to a service error.The ge field engineer (fe) investigated the system and identified the collimator locking ring loosened over the time and two of three set screws used to secure it were missing.The one set screw present appeared to have backed out far enough as to not be useful to keep the collimator in place and resulted in the collimator detachment.The fe also observed there was not any loctite residue on the set screw or surrounding mounting hardware.As a correction, the fe re-tightened the locking ring to the interface plate, installed the three new set screws with loctite and tightened them to the specified torque per the installation manual.The root cause of the collimator detaching is therefore a servicing error where the fe installing the collimator did not use loctite when installing the set screws.The systems service history was evaluated, and it was determined the collimator was last removed from the system in 2017 due to a faulty tube replacement.The fe that performed this tube replacement is no longer a ge employee and therefore no further actions are needed.

• Brand Name: LEGACY/LEGACY-D TABLE
• 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: 9860019
• MDR Text Key: 194012082
• Report Number: 2126677-2020-00002
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K862120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46-262751G7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 102