MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC REVOLUTION CT; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSRV05

Device Problem Mechanical Problem (1384)

Patient Problem Brain Injury (2219)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.

Event Description

It was reported that, while servicing the device, a field engineer bent over and was struck on the top of the head by the detector trolley.He checked his head and didn't feel blood, so he kept working.Twenty days later he was diagnosed with a subdural hematoma.

Manufacturer Narrative

Three field engineers were upgrading a merc80 detector to a merc160 detector.While removing the old detector, the detector slid in the jib crane and hit one of the feâ¿¿s on the top of the head, sustaining a subdural hematoma.There were two root causes that were identified that led to the injury to the field engineer.Improper design of the jib crane assembly: the jib crane was designed to ensure that the angle of the arm when preloaded would be 0 degrees.This would ensure that the hoist and detector would not be able to slide freely when inside of the jib arm.However, when attached the mast on the gantry, the preloaded jib angle was less than 0 degrees which could allow the detector to slide freely.Incomplete deinstallation detail: the procedure provides great detail in the text of how to remove the detector from the gantry and place it onto the detector sled.However, key pictures were missing which would provide important information for removing the detector.There is no installed base of these cranes.The two existing cranes are in quarantine.First, there will be procedural updates to include additional pictures in the service procedure to provide greater detail of the detector removal process.The addition of pictures will reduce the risk incorporated with removing the detector from the gantry.

• Brand Name: REVOLUTION CT
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8584604
• MDR Text Key: 144241680
• Report Number: 2126677-2019-00003
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K133705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CSRV05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other