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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 Problem Failure to Analyze Signal (1539)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Event Description
During an electrophysiological procedure, the display of live signals became delayed by approximately 30 seconds and the procedure was cancelled with no consequences to the patient.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.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.Based on the information received, the cause of the reported signal issue and subsequent cancellation remains unknown.
 
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Brand Name
WM CLARIS CPU
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key12445874
MDR Text Key270507099
Report Number2184149-2021-00275
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067009777
UDI-Public05415067009777
Combination Product (y/n)N
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH700977
Device Catalogue NumberH700977
Device Lot Number6386886
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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