MAUDE Adverse Event Report: PHILIPS HEALTHCARE INFORMATICS, INC. INTELLISPACE PACS BREAST SUITE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problem Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

In the pacs suite for mammography images, in the diagnostic view (lm view)the pacs will read and label the left 3d tomo indicator bar as reversed in orientation on pacs on breast tomos (i.E.Lateral breast registers as "m" for medial, and vice versa) for the hologic affirm prone biopsy system and the ge essential with senoclaire.This has been recognized by the radiologists and they are aware of its occurrence.Philips was first contacted about this observation in (b)(6) 2020.

• Brand Name: INTELLISPACE PACS BREAST SUITE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): PHILIPS HEALTHCARE INFORMATICS, INC.; 4430 rosewood drive, suite 200; pleasanton CA 94588
• MDR Report Key: 10559572
• MDR Text Key: 207728665
• Report Number: 10559572
• Device Sequence Number: 1
• Product Code: LLZ
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 09/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1