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

Model Number 728306

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  No Answer Provided  

Event Description

The customer reported that when they utilized iterative model reconstruction (imr) on cardiac calcium score procedures, the calcium score results are significantly different compared to the results when filtered back projection (fbp) and idose are utilized.A philips technical trainer confirmed this issue was recognized by the trained professional and there was no misinterpretation, mistreatment, or rescan of a patient.The customer has different treatment plans for patients based on the calcium score results and when imr is utilized it creates an unexpected higher score result.

Manufacturer Narrative

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

• 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
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 3688043
• MDR Text Key: 18568162
• Report Number: 1525965-2014-00047
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1