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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number 3000098713
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
Pt had just had decannulated ecmo from left femoral artery. After providers left the iabp alarmed that it was "unable to inflate" and then fixed itself. After a little while longer it started to alarm again. Rn looked down and there was 1 inch of dark red blood coming back into the helium tubing. Immediately put in standby and clamped it. Rn then called a provider to come pull the iabp. The provider pulled the device. No issues during removal. Had to increase patient vasopressor need but otherwise stable. Patient currently does not need another device inserted.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key9601579
MDR Text Key175404273
Report Number9601579
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3000098713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2019
Event Location Hospital
Date Report to Manufacturer01/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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