MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	09-1462-0056
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During a procedure a cancellation occurred due to a loss of signal from the amplifier.To resolve the issue the amplifier was power cycled but it did not properly startup.All connections were check but the issue was not resolved.The procedure was cancelled and rescheduled.There were no adverse patient consequences.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.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 received, the cause of the reported signal issue and subsequent cancelled procedure could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: one ep-workmate¿ scu-signal conditioning unit, 56 channel was received for evaluation.The returned workmate amplifier was powered on but no communication was established with the test standard workmate computer.The amplifier was power cycled several times but no communication was established.The single board computer (sbc) was temporarily replaced with a known good board and successful communication was established with the test standard workmate computer.Using the test standard sbc board, a basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed and confirmed that the returned amplifier performed within the factory specifications.Based on the information provided to abbott and the investigation performed, the root cause of the cancelled procedure was isolated to the single board computer.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8980076
• Report Number: 2184149-2019-00163
• Device Sequence Number: 13511771
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2019

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: 09-1462-0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 11/21/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/23/2019; 12/04/2019
• 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