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	01/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to the procedure with the patient in the room, the amplifier would not connect with the claris pc and the procedure was cancelled.The fiber optic and media converter were replaced with no resolution and the procedure was rescheduled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
One workmate claris amplifier was received for evaluation.The returned workmate claris amplifier was powered on, but no communication was established with the test standard workmate claris computer due to a non-functional sbc.Further investigation of the non-functional sbc revealed a missing network adapter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.

• 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: 11222749
• Report Number: 2184149-2021-00023
• Device Sequence Number: 3745082
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 7235332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other