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

Model Number IMPAX CV RM 2.08

Device Problem Programming Issue (3014)

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

Event Date 02/14/2014

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 7th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).The customer, the initial reporter, in this new event contacted agfa on february 14, 2014 and reported a reading physician had discovered an incorrect statement in the pulmonary artery findings within their rmat reporting.The customer confirmed there were no reports of patient harm during this event.The customer stated no rmat customization requests had been made to agfa, and the site's super user had not made any custom changes to the pulmonary artery findings within the reporting tool, abiding by agfa's rmat terms of use.The customer described when reports were created for trans esophageal echocardiogram (tee), transthoracic echocardiogram (tte) and stress (str) studies, and when the end-user selected the "mild to moderate" radio button in the pulmonary artery pathology section, the incorrect sentence finding of "there is mild to moderate pulmonary hypotension" was generated in the report.The sentence finding should read "there is mild to moderate pulmonary hypertension." the same day the customer reported the event, agfa corrected the statement in both the test and production environments and; in turn, the customer reviewed the correction and confirmed the statement was reading correctly with "hypertension" versus "hypotension".Agfa confirmed rmat super user was disabled.

Manufacturer Narrative

Eval summary: agfa is currently reviewing the rmat logs to identify when the customization change was introduced into the production environment.(b)(4).Agfa's clinical analyst also determined from a study selected from the potentially affected rmat log, that the incorrect sentence finding line was located directly above the actual measurements (which are correct) and that a user would be more likely to look at the actual measurements in a report to formulate conclusions and treatment decisions; an inclination as to why the reading physicians missed the incorrect sentence finding of "hypotension" versus "hypertension " in the many previous pulmonary artery pathology reports.A reportable correction is underway for this issue and has been reported to the fda.Fda reference# is z-2112-10.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.(b)(4).

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HEALTHCARE CORP; 1 crosswind rd; westerly RI 02891
• Manufacturer Contact: debbie huff ; 10 south academy st; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4113586
• MDR Text Key: 4942582
• Report Number: 1225058-2014-00249
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2014

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: Health Professional
• Device Model Number: IMPAX CV RM 2.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1