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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL EP-WORKMATE EP-4 TOUCHSCREEN COMPUTER COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL EP-WORKMATE EP-4 TOUCHSCREEN COMPUTER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 09-1694-1002
Device Problem Loss of Threshold (1633)
Patient Problem Cardiac Arrest (1762)
Event Date 06/19/2021
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, field service was conducted on the device and no alleged deficiency was noted. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined that no non-conformance's were identified that are related to the reported event. Based on the information received, the cause of the reported incident could not be determined.
 
Event Description
During an atrial fibrillation ablation procedure, the patient came in already in atrial fibrillation. The patient then went into cardiorespiratory arrest and the stimulation function of the abbott device did not function for four minutes when attempted to be used for the patient's condition. Despite several device restarts, the issue remained. A heart massage was then given as stimulation was not able to be delivered. The procedure was unable to be completed and the patient was sent to the intensive care unit for three days.
 
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Brand NameEP-WORKMATE EP-4 TOUCHSCREEN COMPUTER
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key12202547
MDR Text Key262643882
Report Number2184149-2021-00221
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number09-1694-1002
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 Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2009
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: 07/21/2021 Patient Sequence Number: 1
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