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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Nausea (1970); Tachycardia (2095)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy that the patient became nauseous, the heart rate rose to 150, and the customer was concerned because the balloon indicator on the screen did not indicate full inflation. The emergency service specialist explained to the customer that this indictor was not an accurate indicator of amount of inflation but rather a motion indicator and also explained that the pump worked within the confines of one cardiac cycle therefore with the high heart rate the pump could not be as effective. The patient coded twice. The patient was semi-stable at the end of the call.
 
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Brand NameSENSATION 7FR. 34CC IAB
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 Key7794588
MDR Text Key117564931
Report Number2248146-2018-00508
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2021
Device Catalogue Number0684-00-0433
Device Lot Number3000068051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/17/2018 Patient Sequence Number: 1
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