MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION REVOLUTION EVO 3.5 L; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number D3887T

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Patient data not provided due to country privacy laws.Initial reporter data not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that the ge field engineer was involved in closing the left gantry cover, hitting the border of the "funnel shapes metal component" just behind.He received a cut on the left thumb and needed to receive 5 stitches.

Manufacturer Narrative

Ge healthcare engineering determined that the cause of the injury to the field engineer¿s hand was improper tool usage due to lack of attention.Fe's left hand was pinched by edge of bracket.Fe's left hand slammed involuntary.The allen wrench slipped from a head of the screw.Fe did not ensure wrench was properly engaged into screw head before applying force.Lack of attention to use a tool.It is concluded that this is not design or part quality issue, but ehs issue due to workmanship.Focused attention and ppe(gloves) will prevent a recurrence of this injury.

• Brand Name: REVOLUTION EVO 3.5 L
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 7-127, asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer (Section G): GE HEALTHCARE JAPAN CORPORATION; 7-127, asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer Contact: jason kelly ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 6036320
• MDR Text Key: 57708026
• Report Number: 9612283-2016-00005
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K131576
• 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: 10/18/2016

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: D3887T
• Device Lot Number: 193428GI0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• 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