MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING XELERIS 3.1 WORKSTATION; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number NX31PR

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 12/22/2014

Event Type  Injury  

Event Description

The customer reported a patient cardiac scan was processed on a xeleris 3.1 workstation.The patient was diagnosed as "normal" following an interpretation the physician had made.The cardiac exam was performed as a pre-operative test for a gallbladder surgery that was prescribed for the patient.A week after the cardiac exam reading, a gallbladder surgery was performed.On the same day of the surgery, the patient suffered a heart attack.As a result, a catheterization was performed that day, and a bypass surgery was performed on the patient the following day.The event is currently under investigation.

Manufacturer Narrative

Patient weight unknown at this time.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.

Manufacturer Narrative

The investigation revealed the device and interface performed as designed and intended with a correct response.There was no malfunction of the device and the data was accurate.The camera and software performed technically as intended with no malfunction or failure.The root cause was identified as unintended misinterpretation of significant clinical information by user.

• Brand Name: XELERIS 3.1 WORKSTATION
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING; tirat hacarmel; haifa, 3020 0; IS 30200
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING; tirat hacarmel; haifa, 3020 0; IS 30200
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4458868
• MDR Text Key: 5318962
• Report Number: 9613299-2015-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NX31PR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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
• Patient Age: 67 YR