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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET, INC. (DATASCOPE CORP.) SENSATION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET, INC. (DATASCOPE CORP.) SENSATION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0469-01U
Device Problems Complete Blockage (1094); No Display/Image (1183); Flushing Problem (1252); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)
Patient Problem No Information (3190)
Event Date 07/21/2016
Event Type  malfunction  
Event Description
Patient's balloon pump arterial balloon pressure on monitor showed no reading at 1030. Balloon pump was alarming "optical sensor not working". The first balloon pump console was switched to another console, but the "optical sensor not working" also appeared on the second balloon pump. Physician attempted to slave the balloon pump to monitor but it did not work. The arterial line transducer was switched with the balloon pump transducer to see if the balloon pump numbers would cross over to the monitor but it did not work. Physician determined it was optic sensor in the central balloon pump lines and that could only be fixed by putting in a new balloon pump line. Physician attempted to flush the balloon pump line but he was unable and then determined the line was clotted. Patient was taken for open heart surgery and a new iabp was placed.
 
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Brand NameSENSATION
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET, INC. (DATASCOPE CORP.)
15 law drive
fairfield NJ 07004
MDR Report Key5868036
MDR Text Key51828567
Report Number5868036
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
Type of Report Initial
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/21/2016
Device Catalogue Number0684-00-0469-01U
Device Lot Number3000025790
Other Device ID Number7FR.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2016
Event Location Hospital
Date Report to Manufacturer08/01/2016
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?
Type of Device Usage

Patient Treatment Data
Date Received: 08/11/2016 Patient Sequence Number: 1
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