MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS SYSTEM 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	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure with the patient on the table, the amplifier did not communicate with the pc and the procedure was cancelled.When powered on, only one beep was heard instead of three.Troubleshooting did not resolve the issue and the case was cancelled.
Additional Manufacturer Narrative
One workmate¿ claris¿ system amplifier was received for evaluation.Visual inspection verified the rear ports, frontal ports, labels, and chassis were free of physical damage.Functional testing revealed when the amplifier was powered on, communication was unable to be established.An external monitor was connected to the single board computer (sbc) and it was observed the network adapter was non-functional.The sbc was temporarily replaced with a known-good unit and functionality was restored.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the single board computer.

• Brand Name: WORKMATE CLARIS SYSTEM AMPLIFIER
• 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: 11884865
• Report Number: 2184149-2021-00182
• Device Sequence Number: 3710467
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: Other
• Device Model Number: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 7061240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1