MAUDE Adverse Event Report: GE HEALTHCARE LIGHTSPEED XTRA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 01/24/2019

Event Type  malfunction  

Event Description

During the introducer needle placement, instead of placing needle into the anterior upper left lung apices, the needle was placed into the left ventricle of the heart.This resulted because of font similarities between the numbers and letters on the ge monitoring system; it was mistakenly read wrong prior to the original planning.Rather than being read as "i 80", it was read as "180", therefore causing the proceduralist to insert the needle lower in the chest.The suggestion is to double check and read back the letter and number as "inferior 80" during the planning location number between the technologist and the radiologist.It has been previously suggested to the ge monitoring company, the manufacturer of the ct scanner, to please change the font of the lettering and numbering to avoid confusion.Manufacturer response for system, x-ray, tomography, computed, lightspeed xtra (per site reporter).The interventional radiology managers have alerted the ge engineer and the ge company representative for our facility.Here is what i got back from ge regarding the id numbers for the monitor & software.Approximate age of device: 11 yrs.Other device number: sw version: (b)(4).This is a computed tomography device.I spoke to the ge engineer about the incident itself as well.I will follow up with an email to include the ge company representative as well.

• Brand Name: LIGHTSPEED XTRA
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HEALTHCARE; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 8436529
• MDR Text Key: 139371405
• Report Number: 8436529
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019,01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22630 DA
• Patient Weight: 75