MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ COMPUTER; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number	H700977
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
When starting the equipment, with the patient in the room, there were communication issues resulting in cancellation of the procedure.First the workmate claris amplifier disconnected, then shortly after an ep-4 off or not connected error showed on the workmate claris display workstation review screen.The ep-4 touchscreen was on and functioning, so the workmate claris system was restarted.The workmate claris amplifier turned on, but the ep-4 stimulator remained disconnected.After a few minutes the workmate claris amplifier lost connection once again and the procedure was postponed.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one wm claris dws was returned for investigation.Visual inspection revealed rust on the back exterior of the unit, the foot was broken off, the ep stim connector was pushed inside the unit and the serial card was missing.The frame grabber was laying on the bottom of the unit and not attached.Power was applied to the unit and connected to a known good claris amplifier.This was run for an extended period of time and connection was stable.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.The reported issue of communication was not confirmed and functioned as intended.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• Common Device Name: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18268932
• Report Number: 2184149-2023-00235
• Device Sequence Number: 7672625
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: H700977
• Device Lot Number: 5268170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown