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

Model Number	H700150
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During patient preparation with the patient in the room, no ecgs were noted on the screen, only flat blue lines were visible even after amplifier was showing connected.After multiple restarts and changing the power source, the issue remained and the case was cancelled.The procedure had to be postponed to the next day.
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.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.
Additional Manufacturer Narrative
One workmate¿ claris¿ display plus amplifier mn h700150 sn (b)(6) was received for analysis.The reported event was duplicated through product testing.Based on the information provided to abbott and the investigation performed, root cause of the field reported event was isolated to abnormal functionally of the bio/stim switch circuit board and the single board computer board.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¿ AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20171968
• Report Number: 2184149-2024-00159
• Device Sequence Number: 18205227
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: (01)05415067001504(10)8910160
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151911
• 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,Followup
• Report Date (Section B): 03/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 8910160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 02/24/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/20/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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