MAUDE Adverse Event Report: PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS ISITE PACS 4.X

Model Number 835021

Device Problem Device Stops Intermittently (1599)

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

Event Type  malfunction  

Event Description

The customer has configured hanging protocol (hp) configuration of "fit to window" as the zoom factor.The customer stated that there was an intermittent issue in that some series were zoomed and some were not when axial images are linked, and then ¿dragged and dropped¿ onto the monitor.The customer indicated that a particular region was not included in one of the images that were zoomed.The customer indicated that the region is captured if using hp with a matrix of 1 presentation.An adverse event did not occurred, no misdiagnosis was made; no treatment rendered; same physician was manually changing the zoom on the images and noticed that the default fit to window zoom did not show all the pathology.

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Manufacturer Narrative

Investigation identified a product anomaly was found resulting from changes in values of pixel spacing (0028,0030) dicom tag between images.Whenever a user moves from an image with one type of pixel spacing to another image which has a different pixel spacing on the same window where linking is enabled, then fit to window zoom factor may be incorrect.Investigation of issue indicates that it would be obvious to the user that if the fit to window images showed the full region of interest and the zoomed images did not as they are viewed at the same time on the monitor; linked images are viewed as a supplement reference only to individually viewed images which are primarily used for diagnosis; there is a reference image available which would immediately indicate to the user that some of the images are zoomed.The zoom magnification value is shown on the images.A ¿linked icon¿ is also shown on the series/images that are linked to remind the radiologist they are viewing linked images.In conclusion, the risk reported issue has been reviewed and it does not pose a risk that would cause or contribute to an adverse event, if it were to recur, would not be likely to cause or contribute to a death or serious injury.

• Brand Name: ISITE PACS 4.X
• Type of Device: ISITE PACS
• Manufacturer (Section D): PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS; 4100 east third ave.; ste. 101; foster city CA 94404
• Manufacturer Contact: nancy ataide ; 4100 east third ave.; ste. 101; foster city, CA 94404
• MDR Report Key: 4644597
• MDR Text Key: 5679730
• Report Number: 2954704-2015-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K063267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 835021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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