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

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 07, 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 an agfa product quality manager.Agfa's investigation into this occurrence or rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: no abscess is visualized in the mitral valve" has been changed to: "there is a hyperechoic mass associated with the mitral valve".In this issue, the original sentence indicates the absence of abscess in the mitral valve.This has been changed to contain a contradictory clinical finding indicating the presence of a hyperechoic mass on the valve, which clinically could inaccurately lead the reader to think that the patient may have a thrombus or possible a rhabdomyoma, which is a common cardiac hyperechoic mass type.If this sentence change exists in actual reports, the ca believes that the reader would look at the images to correlate as there would be no mass dimensions recorded anywhere; this would have the potential to lead to inappropriate diagnosis, and potentially lead to inappropriate treatment.The reader would most likely be confused if the sentence change had corrupted historical data where the original cardiologist had documented the absence of an abscess which was changed to a hyperechoic mass is present, when there as actually no mass present at all.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 patient.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.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 documented in the ongoing cfr part 806 reporting.

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HEALTHCARE CORPORATION; 1 crosswind rd.; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4293412
• MDR Text Key: 5084600
• Report Number: 1225058-2014-06287
• 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
• Report Date: 11/24/2014

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