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

Model Number H700150

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

During a supraventricular tachycardia procedure, while the patient was prepped, it was noted that the workmate claris amplifier had no ecg signal displayed on the workmate claris system.The issue was not resolved, and the procedure was rescheduled.

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.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported signal issue and subsequent cancellation remains unknown.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18423391
• MDR Text Key: 331865474
• Report Number: 2184149-2024-00001
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: 05415067001504
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Model Number: H700150
• Device Lot Number: 5310963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/01/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1