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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. WORKMATE CLARIS SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700123
Device Problems Loss of Threshold (1633); Application Program Version or Upgrade Problem (2881)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation revealed that after the workmate claris (b)(4) software upgrade, the workmate claris dws screen turns black/blank and the user needs to reboot the system to regain functionality.
 
Event Description
During the procedure, there was intermittent pacing and capture. At the start of the case, all 4 pacing channels were selected and assigned to specific poles. Channel 2 was selected first. Pacing behaved as expected. Channel 1 was selected next and pacing appeared to be occurring, but there were only pacing spikes, no capture. Channel 1 was then unassigned and reassigned back to the same pacing site as the original channel 1 site. Pacing began again and the issue was resolved. There was no change in output or catheter location. There were no adverse consequences to the patient. The cause was attributed to a recent upgrade to windows 10 operating software.
 
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Brand NameWORKMATE CLARIS SYSTEM
Type of DeviceCOMPUTER, 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.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key11855277
MDR Text Key251690414
Report Number2184149-2021-00177
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH700123
Device Catalogue NumberH700123
Device Lot Number7634027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2184149-05/05/21-001-R

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