MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728306

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that reconstructions did not complete as expected.The reconstructed images of the 35%, 40% and 45% heart phases of a transaortic valve implantation (replacement) scan (tavi) all appear to be of the same phase.The log files were reviewed and it was confirmed the operator is starting the final reconstructions without reviewing the electrocardiogram (ecg) wave and the images reconstruct without the necessary ecg data.The images are then reconstructed as a non-gated scan, but they are labeled incorrectly as the 35%, 40% and 45% phase.The images are used for surgery planning and there is a potential for serious injury if labeled incorrectly.This event is currently under investigation.

Manufacturer Narrative

A philips applications specialist was reviewing previous cardiac scans with the customer and found that reconstructions did not complete as expected for a gated cardiac scan.The reconstructed images of the 35%, 40%, and 45% heart phases of a trans aortic valve implantation (replacement) scan (tavi) all appeared to be of the same phase.The applications specialist confirmed there was no patient impact due to the reported issue.The applications specialist sent a usb drive with log files and image data to be investigated by philips engineering.The common image reconstruction system (cirs) team reviewed the log files and confirmed the correction vectors required by the cirs were not available to reconstruct the planned cardiac phases.The cirs team and console team concluded this is due to the operator not waiting long enough after the scan completes and reviewing the electrocardiogram (ecg) wave.It is necessary to wait for the console to recognize the ecg wave with the r tags so the cirs can receive the correction vectors necessary to reconstruct images of the planned phases.Without the correction vectors, the cirs will average the data acquired during the x-ray on during the 35%, 40% and 45% heart phase and the on line images will appear to be of the same phase.The on-line reconstructed images are not a true 35%, 40%, and 45% cardiac phase and are labeled incorrectly as the planned cardiac phases.Off-line reconstructions can be done to successfully reconstruct images of the desired phases.It was noticed for this scan, the off-line reconstructions still appeared to look the same for x-ray shot 3.This occurred because the patient did not have a stable heart rate.The user exam card for the scan was created to label the 35%, 40%, and 45% phases; however, the original on-line images were not a true 35%, 40%, and 45% cardiac phase and were incorrectly labeled.The philips applications specialist provided additional gated cardiac training and cautioned the operator to wait the appropriate time after the scan is completed and to only use step and shoot scanning for patients with stable heart rates.The cause of this reported issue was due to the operator not reviewing the ecg prior to selecting start final reconstruction of the images.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ICT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8475187
• MDR Text Key: 140891887
• Report Number: 1525965-2019-00013
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728306
• Device Catalogue Number: NCTC780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1