MAUDE Adverse Event Report: AGFA HEALTHCARE CORP IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08); PICTURE ARCHIVING AND COMMUNCATION

Model Number IMPAX CV 2.08

Device Problem Installation-Related Problem (2965)

Patient Problem No Information (3190)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

Agfa submitted mdr report# 1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A (b)(6) occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.

Manufacturer Narrative

An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.Agfa's investigation into this occurrence of rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in pt reports.Specifically: the original sentence finding of "no tricuspid calcification is visualized" has been changed to:" there is a ruptured chordae involving the anterior tricsupid valve leaflet".In this issue, the original sentence states the tricuspid leaflets are without vegetation.The sentence change however, contains clinically different content indicating the presence of anterior tv leaflet chordae rupture.This could lead to incorrect diagnosis and or inappropriate treatment as a chordae rupture would indicate the presence of tricuspid regurgitation and may indicate the need for tv leaflet repair.If this sentence change is found in the production environment, the ca believes that the potential for misdiagnosis is greater than the potential for inappropriate treatment as the referring surgeon would assess the images prior to intervention.Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that pt.As soon as agfa is made aware of any affected reports related to this specific finding, follow-up mdrs will be submitted for each associated study date and respective medical record number/s (mrn) identified.There has been no reported pt harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference # z-2112-10.Agfa will follow the rmat post market verification work instructions to correct the sentence finding.Any further investigation for the site described in this report will be document in the ongoing cfr part 806 reporting.

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNCATION
• Manufacturer (Section D): AGFA HEALTHCARE CORP; 1 crosswind rd.; westerly RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4293353
• MDR Text Key: 5083602
• Report Number: 1225058-2014-06320
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IMPAX CV 2.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1