MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY CT 750 HD; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPH04

Device Problem Unintended Movement (3026)

Patient Problem Head Injury (1879)

Event Date 07/31/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted after the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that while servicing the ct system, a ge field service engineer sustained a head laceration requiring stitches.While replacing the heat exchanger, he removed one of the extension connection pins supporting the positioning dolly; allowing the extension bar to swing down and strike his head.

Manufacturer Narrative

Ge healthcare engineering determined that the cause of the tube host extension arm falling and hitting the service engineer in his head was inattentive removal of the lower connect pin.The extension arm and boom on the positioning dolly are connected by two pins.If the lower connect pin is removed at first the extension arm will swing and drop down normally; this is common sense for a field service engineer (fse).The fse should use a hand to support the arm to prevent the extension arm from swinging down when removing the pins or disassembling the lift tool on the ground instead of on the gantry.In this case, the fse did not follow proper operating process correctly, which caused this problem.

• Brand Name: DISCOVERY CT 750 HD
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: dennis hurley ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 5913973
• MDR Text Key: 53481103
• Report Number: 2126677-2016-00013
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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: No Information
• Device Model Number: CSPH04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other