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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
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 loss and subsequent procedure cancellation was due to user error.
Event or Problem Description
Prior to an electrophysiological exploration procedure, no signal was noted on the system and the procedure was cancelled.The junction box and cables were replaced with no resolution.The procedure was cancelled and rescheduled for a later date.The patient was in the room but was not prepared.There were no adverse consequences to the patient due to the cancellation.Further troubleshooting revealed the signal loss was due to user error.The amplifier passed all functional tests and retraining will be provided to the customer.

• 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: 7902526
• Report Number: 2184149-2018-00161
• Device Sequence Number: 18861699
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/24/2018

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/24/2018
• 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