MAUDE Adverse Event Report: AGFA HEALTHCARE CORP. IMPAX CV12; IMPAX CARDIOVASCULAR (CV12) PICTURE ARCHIVING AND COMMUNICATION

Model Number IMPAX CV12

Device Problem Patient Data Problem (3197)

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

Event Date 05/18/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017 agfa became aware of a second occurrence reported by the customer in which reports crossing from cardio system (cv12.1su1) into epic are showing up with incorrect demographics.The first occurrence has been reported in fda mdr 1225058-2015-14119.Previously the root cause has been identified as product defect within the demographics manager component of impax cv 12.1.Agfa reported to fda via 21 cfr 806 reporting (z-0283-2016) a correction for this issue.The customer declined the correction, however the customer did acknowledge and accept the risk associated with not accepting the corrected version of the software and not removing the affected version of the software.Agfa is working with the customer to resolve this issue.There has been no reported harm to patient or user during this event.A supplemental report will be provided.

Manufacturer Narrative

This supplement report #1 is being submitted to provide corrective actions taken.Previously the customer has declined the correction for the product defect within the demographics manager component of impax cv 12.1.On (b)(6) 2017, the customer has accepted the correction and requested that agfa turn off the demographics manager component.The customer also agreed to upgrade their system to cv12.2 su8 and on (b)(6) 2017 work related to this upgrade began in the customer's test environment.The upgrade to the customer's product environment is scheduled for (b)(6) 2017.Any additonal supplemental reporting will be reported to fda via 21 cfr 806 reporting as an addendum to z-0283-2016.There has been no reported harm to patient or user during this event.

Event Description

This supplement report #1 is being submitted to provide corrective actions taken.

Manufacturer Narrative

Agfa has submitted fda mdr supplemental report # 1225058-2017-00002 sup 1 on july 03, 2017.In this report we have provided the following information: "previously the customer has declined the correction for the product defect within the demographics manager component of impax cv 12.1.On august 22, 2017, the customer has accepted the correction and requested that agfa turn off the demographics manager component.The customer also agreed to upgrade their system to cv12.2 su8 and on august 22, 2017 work related to this upgrade began in the customer's test environment.The upgrade to the customer's product environment is scheduled for august 2017." this supplemental report # 2 is being submitted to provide the correct information.The date of the correction at the customer site has been corrected from august 22, 2017 to june 22, 2017.The corrected information is below: "previously the customer has declined the correction for the product defect within the demographics manager component of impax cv 12.1.On june, 2017, the customer has accepted the correction and requested that agfa turn off the demographics manager component.The customer also agreed to upgrade their system to cv12.2 su8 and on june 22, 2017 work related to this upgrade began in the customer's test environment.The upgrade to the customer's product environment is scheduled for august 2017.".

Event Description

This supplement report #2 is being submitted to provide corrected information.

• Brand Name: IMPAX CV12
• Type of Device: IMPAX CARDIOVASCULAR (CV12) PICTURE ARCHIVING AND COMMUNICATION
• 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 s academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 6613984
• MDR Text Key: 76956243
• Report Number: 1225058-2017-00002
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2017

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: No Information
• Device Model Number: IMPAX CV12
• Device Catalogue Number: CV12.1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/22/2017; 08/10/2017
• Supplement Dates FDA Received: 07/03/2017; 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1