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

Model Number	09-1462-0056
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the procedure a spark was seen when the amplifier was powered on.There were no adverse consequences to the user.The procedure was rescheduled.
Additional Manufacturer Narrative
One ep-workmate scu was received for evaluation.During inspection the returned device would not turn on and the reported sparking was confirmed.The power supply was temporarily replaced with a test standard power supply and normal power was restored.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.The reported event of a spark was consistent with a non-functional power supply.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported spark could not be determined.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8233188
• Report Number: 2184149-2019-00004
• Device Sequence Number: 1910465
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2019

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: 09-1462-0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/18/2019; 03/29/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/19/2019; 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1