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

Model Number H700124

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a power outage, the cpu would not boot back into the program.Despite several power cycling attempts.The procedure was allegedly cancelled.

Event Description

During a power outage, the cpu would not boot back into the program, despite several power cycling attempts.The procedure was beyond the therapy stage so no additional recording or ablation was done after this event.The case was ended and the patient was discharged in stable condition.The patient needed to be rescheduled for a second part of the procedure which was not attempted after the system went down.The system was rebooted and eventually came back online.A ups was installed to resolve the issue.

Manufacturer Narrative

Additional information: b5, g4, g7, h2, h3, h6.A review of the device history record was not possible since the system serial number was provided and the component serial number was not.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 incident could not be conclusively determined.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9382901
• MDR Text Key: 191763519
• Report Number: 2184149-2019-00237
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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
• Device Operator: Health Professional
• Device Model Number: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 6044048
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1