MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ COMPUTER (HP Z600); CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number	100101792
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure the computer displayed a "win32" error message and the software stopped running.The procedure was unable to be completed.
Event or Problem Description
During a procedure the computer displayed a "win32" error message and the software stopped running.The procedure was unable to be completed.No further information is available.
Additional Manufacturer Narrative
One ep-workmate computer was received for evaluation.Visual inspection revealed the input/output connectors had no physical damage.Normal wear was observed on the exterior enclosure.The computer was returned without the hard drives.No further testing was performed due to the missing hard drives.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported complaint of "win32" error could not be confirmed, and the computer was returned without the hard drives and no further testing could be performed.

• Brand Name: EP-WORKMATE¿ COMPUTER (HP Z600)
• Common Device Name: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8633603
• Report Number: 2184149-2019-00096
• Device Sequence Number: 1644342
• Product Code: DQK
• UDI-Device Identifier: 05415067000965
• UDI-Public: 05415067000965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100101792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1