MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PHILLIPS INTELLISPACE 3D SOFTWARE APPLICATION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Incorrect Or Inadequate Test Results (2456); Improper Device Output (2953)

Patient Problem No Information (3190)

Event Date 12/23/2014

Event Type  malfunction  

Event Description

New processing software did not demonstrate pathology as previously seen on ct scan processed from different software.Discrepancy was discovered by radiologist.Exam was reprocessed with old software to demonstrate pathology.

• Brand Name: PHILLIPS INTELLISPACE 3D SOFTWARE APPLICATION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner road; cleveland OH 44143
• MDR Report Key: 4844117
• MDR Text Key: 5871998
• Report Number: 4844117
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR