MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700977
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product's model/lot number was unable to be obtained and therefore full udi information(d4) and 510k(g3) cannot be not provided.
Event or Problem Description
During a supraventricular tachycardia procedure, a noise artifact resulted in the cancellation of the procedure.During the procedure, it was reported the workmate claris computer would not show any signals.It had blue over-saturated signals on the egm.Moving the egm ports did not resolve the issue.The pacing channels brought the signals back to unsaturated, but this was completed after the case was abandoned.The ecg signals appeared as they should during the procedure.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h2, h3, h4, h6 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 noise issue and subsequent cancellation could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19819745
• Report Number: 2184149-2024-00130
• Device Sequence Number: 8694789
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: (01)05415067009777(10)5035049
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5035049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown