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

Model Number	09-1462-0056
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
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
There was no egm display on the workmate claris.The cable connection was checked as well as another cable which did not resolve the issue.The study was cancelled with no patient consequences.
Additional Manufacturer Narrative
Additional information: g4, h2, h3, h4, h6.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.Based on the information received, the cause of the reported display issue and subsequent cancellation could not be conclusively determined.Testing at the hospital confirmed ecg signals were generated as well as both uni and bi-polar egm signals.Neither the cim nor the egm input amplifier had any issues.It is believed that the event was related to patient conditions.

• Brand Name: EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10211328
• Report Number: 2184149-2020-00092
• Device Sequence Number: 2108319
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/24/2020

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
• Device Catalogue Number: 100019209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1