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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. MAQUET IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Inflation Problem (1310); Failure to Calibrate (2440); Inappropriate Waveform (2536)
Patient Problem Insufficient Information (4580)
Event Date 02/15/2021
Event Type  malfunction  
Event Description
Iabp alarmed "unable to calibrate optic cable" constantly throughout shift wave form was not appropriate and caused missed timing on balloon inflation & deflation. The iabp was then placed on semi auto & automatically timed. R-r wave timing was off. Fda safety report id # (b)(4).
 
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Brand NameMAQUET IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ 07004
MDR Report Key11462095
MDR Text Key239424433
Report NumberMW5099913
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
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

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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