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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS/BRACCO S.P.A. EMPOWER CTA/ EMPOWER CTA+ INJECTOR, CONTRAST MEDIUM

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ACIST MEDICAL SYSTEMS/BRACCO S.P.A. EMPOWER CTA/ EMPOWER CTA+ INJECTOR, CONTRAST MEDIUM Back to Search Results
Model Number 87189
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 02/27/2018
Event Type  malfunction  
Event Description
Contrast injectors for ct scan failed during patient used: vendor: bracco-acist, injector name: empower cta (b)(4), serial # (b)(4); vendor: bracco-acist, injector name: empower cta (b)(4), serial # (b)(4).
 
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Brand NameEMPOWER CTA/ EMPOWER CTA+
Type of DeviceINJECTOR, CONTRAST MEDIUM
Manufacturer (Section D)
ACIST MEDICAL SYSTEMS/BRACCO S.P.A.
MDR Report Key7316903
MDR Text Key101839974
Report NumberMW5075690
Device Sequence Number0
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number87189
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/05/2018 Patient Sequence Number: 1
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