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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); Nonstandard Device (1420); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2016
Event Type  malfunction  
Event Description
Agfa submitted mdr report # 1225058-2016-00001, 1225058-2016-00002, and 1225058-2016-00003 to the fda on (b)(6) 2016 for a site in the us. This report is for a 4th occurrence of the same issue at a different site and includes one (1) report affected on (b)(6) 2016, when the error occurred. This was an internal discovery by agfa during the implementation of the associated problem correction plan as reported to fda via 21 cfr 806 reporting via (b)(4) (1225058-12-22-2016-001-c). Report id date error occurred. (b)(4), (b)(6) 2016. Background on november 22, 2016, a customer reported to agfa that when using impax 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. 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 (b)(6) 2016 agfa has implemented a correction via (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 (b)(4) 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 site 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 reportable correction is underway for this issue and has been reported to the fda. Any additional reporting for this correction activity will be reported to fda via 21 cfr 806 reporting via (b)(4) (1225058-12-22-2016-001-c). There have been no reports of physical harm or health damage resulting from this issue.
 
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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 Key6264010
MDR Text Key65689040
Report Number1225058-2017-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050228
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 01/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received01/06/2017
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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