MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS SYSTEM COMPUTER Z620; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700977

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 2184149-2019-00249.During a procedure, the amplifier and dws were booted and an error message ¿amplifier disconnected¿ was displayed and an audible alarm was noted from the dws.The devices were power cycled with no resolution and each time they were power cycled, ¿database read/write/access error¿ would display.A part of the procedure which was atrial fibrillation and supraventricular tachycardia with the use of the ensite system could not be performed and was postponed as the replacement workmate claris devices were unable to be prepared.Therefore, the use of a non-abbott device was required to completed only the atrial fibrillation part of the procedure.

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 error message and subsequent incomplete ablation could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: WORKMATE CLARIS SYSTEM COMPUTER Z620
• Type of Device: 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. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9457687
• MDR Text Key: 170452916
• Report Number: 2184149-2019-00248
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5268159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER