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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
Model Number 0998-00-0800
Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 12/08/2019
Event Type  malfunction  
Event Description
There was a leaking error when using maquet/datascope intra-aortic balloon pump that was canceled last night and today. The patient was found to have air in the iliac arteries on ct. Iabp (intra-aortic balloon pump) was removed. Iabp was sequestered and biomed work order was put in for further evaluation/inspection.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key10133309
MDR Text Key194506933
Report Number10133309
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 05/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2020
Event Location Hospital
Date Report to Manufacturer06/09/2020
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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