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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGFA HEALTHCARE CORP. IMPAX CV REPORTING

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AGFA HEALTHCARE CORP. IMPAX CV REPORTING Back to Search Results
Model Number IMPAX CV12
Device Problems Computer Software Problem (1112); Failure to Read Input Signal (1581); Application Program Problem (2880)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2016
Event Type  Malfunction  
Event Description

We are reporting this mdr reportable event on december 22, 2016. On november 22, 2016, the customer reported to agfa that when using mpax cv reporting for non-invasive vascular ultrasound (niv), when building a niv report, in the conclusion section of the upper arterial duplex, if you select any check boxes under the left aneurysm it puts in the report that there was no aneurysm. This report is for the 2nd of three events for the same issue at this site. The first event is reported in fda mdr 1225058-2016-00001. On november 22, 2016, agfa technical support contacted the customer and updated him that only three (3) reports were affected and those three (3) reports were all listed as test reports. The customer was provided the list of the affected reports. Agfa technical support re-configured the reports to produce correct statements in both the test and production environment. A problem record was created on november 23, 2016 to address the issue via (b)(4). On december 22, 2016 agfa has implemented a correction via agfa id - (b)(4) (1225058-12-22-2016-001-c). Agfa sent urgent safety notices to affected consignees for this issue described in (b)(4) (1225058-12-22-2016-001-c) on december 22, 2016. The letter informed the consignees that agfa services will contact the affected consignees to: execute a query to find all affected reports at the and to provide the results. The query will not require downtime and will not impact system performance. Correct the niv reporting clinical content. The correction activity will not require downtime. The letter also informed customers to contact agfa if they had any questions related to the communication letter. A mandatory service bulletin will be released to provide documentation on how to deploy the correction for this issue with impax cv reporting. Any additional reporting for this correction activity will be reported to fda via 21 cfr 806 reporting via agfa id - (b)(4) (1225058-12-22-2016-001-c). There have been no reports of physical harm or health damage resulting from this issue. This medical device report includes 1 report affected on (b)(6) 2016, when the error occurred. Report id date error occurred: (b)(4) (b)(6) 2016.

 
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Brand NameIMPAX CV REPORTING
Type of DeviceCV REPORTING
Manufacturer (Section D)
AGFA HEALTHCARE CORP.
1 crosswind rd
misquamicut RI 02891
Manufacturer (Section G)
AGFA HEALTHCARE CORP.
1 crosswind rd
misquamicut RI 02891
Manufacturer Contact
cassandra mcgowan
10 south academy street
greenville, SC 29601
8644211984
MDR Report Key6200931
MDR Text Key63611826
Report Number1225058-2016-00002
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050228
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIMPAX CV12
Device Catalogue NumberCV12.2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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