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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP / MAQUET CARDIOVASCULAR LLC IABP MAQUET SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP / MAQUET CARDIOVASCULAR LLC IABP MAQUET SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 2277
Device Problem Inflation Problem (1310)
Patient Problems Hypoxia (1918); No Code Available (3191)
Event Date 04/18/2019
Event Type  malfunction  
Event Description
Very ill pt. Cad, acute hypoxic resp failure. Pt to cath lab for heart cath and iabp placement, cath completed. Pt had bradycardiac arrest. Tried to inflate iabp balloon with multiple inflations without success. Second pump immediately available and placed with success. Fda safety report id# (b)(4).
 
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Brand NameIABP MAQUET
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP / MAQUET CARDIOVASCULAR LLC
MDR Report Key8587282
MDR Text Key144441098
Report NumberMW5086424
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2277
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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