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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Inflation Problem (1310)
Patient Problem Bradycardia (1751)
Event Date 04/18/2019
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 record id : (b)(4).
 
Event Description
The intra-aortic balloon (iab) therapy and heart catheterization was started in a very ill patient with cad, acute hypoxic and respiratory failure. Patient had bradycardia arrest. The customer tried to inflate balloon with multiple inflations without success. Second pump immediately available and placed with success. The facility does not attribute the serious injury to the device.
 
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Brand NameUNKNOWN IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8664087
MDR Text Key146909306
Report Number2248146-2019-00448
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 other,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No
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: 06/03/2019 Patient Sequence Number: 1
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