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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700150
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2023
Event Type  malfunction  
Manufacturer Narrative
One workmate¿ claris¿ display plus amplifier, pn (b)(6) sn (b)(6) was received for evaluation.No accessories or original packaging were available for inspection.Based on the information provided to abbott and the investigation performed, root cause of the field reported event was successfully isolated to an intermittent sbc.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
 
Event Description
During an atrial fibrillation procedure, noise issues with the workmate claris resulted in the procedure being cancelled.It was noted that there were blue lines on the surface electrodes on the workmate claris.Catheters had not been inserted yet.The notch filter was set to 60.Ecg leads and patches were replaced but the issue did not resolve.The workmate claris was rebooted and the issue resolved briefly but then re-occurred.The amplifier was reset and the ensite x belly patch was replaced but the issue did not resolve.The procedure was cancelled.There are no adverse consequences to the patient reported.
 
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Brand Name
WORKMATE¿ CLARIS¿ AMPLIFIER
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.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key16879484
MDR Text Key314904749
Report Number2184149-2023-00096
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067001504
UDI-Public05415067001504
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/05/2023
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 NumberH700150
Device Catalogue NumberH700150
Device Lot Number8078673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/04/2023
Initial Date FDA Received05/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age71 YR
Patient SexMale
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