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

Model Number 100101792

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  Injury  

Event Description

During a procedure the computer displayed a "win32" error message and the software stopped running.The procedure was unable to be completed.

Event 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.

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)
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8633603
• MDR Text Key: 145846887
• Report Number: 2184149-2019-00096
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067000965
• UDI-Public: 05415067000965
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1