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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WM CLARIS CPU COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. WM CLARIS CPU COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700977
Device Problems Computer Software Problem (1112); Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation revealed that after the workmate claris v. 1. 2 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 no pacing output. There were additionally anomalies encountered in software version 1. 2. The device was power cycled and the issue was resolved. The procedure was completed without further issue. There were no adverse consequences to the patient. The device was retained by the customer.
 
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Brand NameWM CLARIS CPU
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 Key11850420
MDR Text Key252083277
Report Number2184149-2021-00171
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 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH700977
Device Catalogue NumberH700977
Device Lot Number6809129
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 Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/19/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2184149-05/05/21-001-R

Patient Treatment Data
Date Received: 05/19/2021 Patient Sequence Number: 1
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