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

Model Number	H700169
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During preparation for the af/afl procedure with the patient on the table, the amplifier did not connect to the dws and the procedure was cancelled.The fiber optic cable connecting the claris amplifier to the dws computer tower was tested and replaced, the media converter and ethernet cable from the media converter to the data port on the claris amplifier were replaced.The system was rebooted which determined the issue was due to the amplifier and the procedure was cancelled.The procedure will be rescheduled.
Additional Manufacturer Narrative
One workmate¿ claris¿ display plus amplifier was received for evaluation.Visual inspection of the returned amplifier indicated the external casing, connectors, switches, and labels had no physical damage.It was also observed that all the expansion cards were fully seated and that all the data cables were secured.No physical damage on the expansion cards, or the components.During the initial power on, it was observed that the returned amplifier passed the startup hardware self-test and initiated communications with the workmate claris workstation as expected.The unit was power cycled several times with no breaks in communication observed.A communication test was performed at the correct rate of approximately 2000 packets/second.It was verified the amplifier did not encounter errors or missing packets during the communication test.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 provided to abbott and the investigation performed, the root cause of the reported event cannot be conclusively determined as no abnormalities were identified.The returned claris amplifier functioned as designed during the evaluation period.
Additional 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 communication issue and subsequent cancellation remains unknown.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18768405
• Report Number: 2184149-2024-00036
• Device Sequence Number: 11858902
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151911, K21
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2024

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: H700169
• Device Lot Number: 7357731
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 04/22/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/16/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2017
• 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