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

Model Number	09-1463-0120
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to an electrophysiology procedure, the amplifier displayed the message ¿no display - please check connection¿ and a spark was observed followed by a burning smell.The amplifier was power cycled and a loud continuous beeping sound came from the amplifier.The patient was moved to another room and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The returned ep-workmate amplifier would not power on.The power supply was temporarily replaced with a test standard power supply and normal power was restored.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.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 investigation, the cause for the sparking and burning smell could be attributed to the nonfunctional power supply.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 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: 7761424
• Report Number: 2184149-2018-00124
• Device Sequence Number: 1280614
• Product Code: DQK
• UDI-Device Identifier: 05415067003119
• UDI-Public: 05415067003119
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 09-1463-0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1