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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. WORKMATE CLARIS DISPLAY PLUS AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H700150
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
 
Event Description
Related manufacturer reference: 2184149-2019-00248. During a procedure, the amplifier and dws were booted and an error message ¿amplifier disconnected¿ was displayed and an audible alarm was noted from the dws. The devices were power cycled with no resolution and each time they were power cycled, ¿database read/write/access error¿ would display. A part of the procedure which was atrial fibrillation and supraventricular tachycardia with the use of the ensite system could not be performed and was postponed as the replacement workmate claris devices were unable to be prepared. Therefore, the use of a non-abbott device was required to completed only the atrial fibrillation part of the procedure.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received the cause of the reported error message and subsequent incomplete ablation could not be determined. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
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Brand NameWORKMATE CLARIS DISPLAY PLUS AMPLIFIER
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. (AF-ST. PAUL)
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9457700
MDR Text Key170449384
Report Number2184149-2019-00249
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH700150
Device Catalogue NumberH700150
Device Lot Number5286366
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 Received03/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/12/2019 Patient Sequence Number: 1
Treatment
WORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620
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