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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) WI-BOX TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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ST. JUDE MEDICAL, INC. (AF-ST. PAUL) WI-BOX TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number C12783
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Event Description
The quantien was turned on and a guidewire was prepared for an ffr procedure. However, the pa displayed an error message of "no source". Upon checking the wi-box, both the red and green light were on. The cables were unplugged, and replugged but the quantien displayed an error message of "signal lost". The ao in was then unplugged, and both the lights on the wibox (green and red) were turned on again, and the quantien displayed error message of "no source". The procedure was unable to proceed and was rescheduled. The wi-box was inspected and was determined to be faulty. It was then replaced, and the issue was resolved.
 
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Brand NameWI-BOX
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8528504
MDR Text Key142392105
Report Number2184149-2019-00041
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K111854
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 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC12783
Device Lot Number6391658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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