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

Model Number	H700150
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, when the cpu and the amplifier were properly connected and the patches for the 12-lead body surface ecg were attached to the patient, an error message "amplifier errors" was displayed and the waveform did not display at all.The system became connected when "clear error" was performed through the communication test, however, the error was again displayed.The amplifier and cpu were power cycled with no resolution.The procedure was abandoned and there were no adverse consequences to the patient.
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.Based on the information received, the cause of the reported incident could not be determined.
Additional Manufacturer Narrative
One workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed and confirmed that the returned amplifier performed within the factory specifications.The communication test was run for over 60 hours and no interruption or drop in communication was observed.No error message was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.The cause of the reported event is unknown as the device functioned as intended.

• Brand Name: WORKMATE CLARIS DISPLAY PLUS 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: 8227624
• Report Number: 2184149-2019-00001
• Device Sequence Number: 1961472
• Product Code: DQK
• UDI-Device Identifier: 05415067017031
• UDI-Public: 05415067017031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2020

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: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 6513896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 02/22/2019; 10/09/2020
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/31/2019; 02/22/2019; 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1