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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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ST. JUDE MEDICAL, INC. QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number C12787
Medical Device Problem Code Sparking (2595)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/07/2019
Type of Reportable Event Malfunction
Event or Problem Description
The quantien system could not be turned on to view a case because it was wet with contrast.A short circuit occurred, and a spark was noted.There was no patient involvement.
 
Additional Manufacturer Narrative
One quantien was returned for analysis.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was isolated to fluid ingress to the power supply unit which resulted in the subsequent short circuit.
 
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Brand Name
QUANTIEN
Common Device Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key8369581
Report Number2184149-2019-00020
Device Sequence Number11037309
Product Code DQK
UDI-Device Identifier05415067000996
UDI-Public05415067000996
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K123984
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberC12787
Device Lot Number9999999999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 02/07/2019
Supplement Date Received by Manufacturer05/30/2019
Initial Report FDA Received Date02/26/2019
Supplement Report FDA Received Date06/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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