MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100019203
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
During a supraventricular tachycardia ablation procedure a cancellation occurred.Following patient prep, the amplifier was powered on and intermittent connection occurred.The amplifier and media converter were power cycled without resolution.The fiber optic and ethernet cables were replaced and the issue still did not improve.The procedure was cancelled with no adverse patient consequences.
Additional Manufacturer Narrative
One workmate claris amplifier with was received.The workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.However, the communication dropped and an error ¿amplifier disconnected¿ message was received on the live screen of the workmate claris system indicating that the communication between the workmate claris system and the amplifier terminated unexpectedly.During the evaluation, the amplifier status was reviewed including the single board computer (sbc) temperature and voltage sensors.The amplifier status revealed fluctuating microprocessor core temperature that exceeded the predetermined limit during operation.As designed, the single board computer initiated a system shutdown as the microprocessor operating temperature approaching a predefined threshold.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the evaluation performed, the returned amplifier intermittently loss communication with the work mate claris computer due to the single board computer (sbc) temperature fluctuation exceeding the predetermined limits.Using a test standard sbc, the communication tests was performed for several hours and no interrupted or loss of communication was observed.The root cause of the intermittent connection and subsequent cancelled procedure was isolated to an intermittent sbc board.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8950654
• Report Number: 2184149-2019-00157
• Device Sequence Number: 2418182
• Product Code: DQK
• UDI-Device Identifier: 05415067003119
• UDI-Public: 05415067003119
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/17/2019

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: 100019203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other