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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 09-1463-0120
Device Problem Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 01/04/2018
Event Type  Injury  
Manufacturer Narrative
The reported incident could not be reproduced during the hardware evaluation. The results of the hardware evaluation confirmed proper functions of the returned amplifier such as communication, signals acquisition/amplification and data processing. No abnormal operating symptoms or unexpected abnormal functions under normal operating condition were observed. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with manufacturing specifications and procedures. Based on the information provided and the hardware evaluation performed, the cause of the reported noise could not be conclusively determined.
 
Event Description
During the procedure, noise was noted when selecting the pacing channel without pacing. Troubleshooting included checking settings, changing the ecg cable and pin box, and changing the location on the pin box. The procedure was cancelled.
 
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Brand NameEP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key7219994
MDR Text Key98275333
Report Number2184149-2018-00013
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
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number09-1463-0120
Other Device ID Number05415067003119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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