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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 11/02/2016
Event Type  Death  
Manufacturer Narrative
The product is not expected to return for evaluation. A supplemental report will be sent if additional information is received. (b)(4).
 
Event Description
Account reported the following: continued to see "check intra-aortic balloon catheter' message. Pump continued with following message- "check iabp catheter" patients condition was critical. Patient was in for a coronary artery bypass graft procedure. Patient also had aortic valve disease.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6125328
MDR Text Key60805482
Report Number2248146-2016-00093
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received11/03/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/23/2016 Patient Sequence Number: 1
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