MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ 120 CHANNEL FULL SYSTEM, 110V; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number	100013106
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
At the start of a procedure, the error message "check all connections" was displayed.The system was power cycled but the amplifier would not connect and the issue could not be resolved.The patient was on the procedure table when the case was cancelled.There were no adverse consequences to the patient.
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 incident could not be determined.

• Brand Name: EP-WORKMATE¿ 120 CHANNEL FULL SYSTEM, 110V
• Common Device Name: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8032708
• Report Number: 2184149-2018-00176
• Device Sequence Number: 1302583
• Product Code: DQK
• UDI-Device Identifier: 05414734207546
• UDI-Public: 05414734207546
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 100013106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1