MAUDE Adverse Event Report: AGFA HEALTHCARE CORP. 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 7, 2010 for a site in the us.A (b)(6) occurrence is being reported for the same issue/same device: impax cv resulted 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.An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.

Manufacturer Narrative

Agfa's investigation into this occurence of rmat customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: the original sentence finding of "the septum has abnormal paradoxical motion consistent with being ventilation-related" has been changed to:" there is abnormal septal motion that appears to be at least partially due to the pt's left bundle branch block".In this issue, the original sentence finding attributes the paradoxical septal motion to ventilation.The changed sentence attributes the septal motion to something with a significant different clinically meaning: that of a cardiac conduction abnormality called a "left bundle branch block" or lbbb.This sentence change if present is not what the reading physician intended.Normally, the septum moves away from the sternum and towards the posterior lv during systole.While paradoxical septal motion, in which the ventricular septum moves anteriorly towards the sternum during systole, occurs in pts with asd or some other cause of right ventricular overload.There are many potential causes of abnormal septal motion such as lbbb, wolff - parkinson- white syndrome, asymmetric septal hypertrophy, congestive cardiomyopathy, coronary artery disease, and post aortic or mitral valve replacement.The ca believes that misdiagnosis of lbbb as the cause of the paradoxical septal motion is possible in this instance if the sentence change is found on any actual reports, but believes that the prudent practitioner would correlate the finding with the pts ecg prior to initiating any treatment regimens.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 patient 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 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 CORP.; 1 crosswind rd.; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4293395
• MDR Text Key: 5056090
• Report Number: 1225058-2014-06302
• 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