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U.S. Department of Health and Human Services

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

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GETINGE / DATASCOPE CORP. GETINGE INTRA AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 068400057601U
Device Problem Material Rupture (1546)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/26/2021
Event Type  Injury  
Event Description
Pt had iabp placed without incident. Blood noted in tubing 20 mins after placement. Iabp removed. Iabp had ruptured. New iabp inserted without incident.
 
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Brand NameGETINGE INTRA AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE / DATASCOPE CORP.
MDR Report Key11251007
MDR Text Key229604871
Report NumberMW5099091
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number068400057601U
Device Catalogue Number068400057601U
Device Lot Number3000133770
Was Device Available for Evaluation? Device Returned to Manufacturer
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

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