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

Model Number H700123

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission. .

Event Description

During a diagnostic exploration procedure, the signal leads would not display on the recording system and the procedure was cancelled.The procedure was completed at a different facility.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

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.Additional information from the field confirmed the system is functional and still in use at the customer facility.Based on the information received, the cause of the reported signal loss and subsequent procedure cancellation could not be conclusively determined.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• 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: 8980860
• MDR Text Key: 157093667
• Report Number: 2184149-2019-00165
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700123
• Device Lot Number: 5816016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other