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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS USA CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC
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MAQUET MEDICAL SYSTEMS USA CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Device Problems Fail-Safe Design Failure (1222); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2016
Event Type  malfunction  
Event Description
The maquet cardiosave hybrid balloon pump has a poorly designed top panel.The panel is designed such that any liquid that finds its way into this area will be funneled directly into the 14 pin monitor connection site.When saline was applied to this connection site the machine shut down.The top panel is labeled with signage discouraging the placement of iv bags in this area.However in practical use fluid will find its way onto this panel.Even a small amount of liquid will flow directly to the monitor connection site because of the funnel design.This top panel should be redesigned to prevent the flow of liquid into the monitor connection site or a liner should be applied to the top panel to collect liquids and prevent their flow into the monitor connection site.
 
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Brand Name
CARDIOSAVE HYBRID
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond dr
wayne NJ 07470
MDR Report Key5815023
MDR Text Key50182723
Report Number5815023
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/06/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer07/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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