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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01U
Device Problem Backflow (1064)
Patient Problem Failure of Implant (1924)
Event Date 05/14/2019
Event Type  malfunction  
Event Description
Balloon pump alarmed "check iabp catheter". At this time the augmented waveform went flat and blood flashed back into the helium line. Balloon pump was immediately put on stand by. Physician called immediately and came to bedside. Md stated patient needed to go back to operating room to have balloon removed. Operation room team called in. Manufacturer response for fiber-optic balloon catheter, and insertion kit, maquet (per site reporter). Biomed tech contacted manufacturer's tech support and informed them of the issue. Tech support stated this was something that has the potential to happen and provided the biomed technician with the recommended parts that needed to be replaced due to the incident. No case was created with the manufacturer.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr
fairfield NJ 07004
MDR Report Key8869408
MDR Text Key153534414
Report Number8869408
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 Biomedical Engineer
Type of Report Initial
Report Date 06/10/2019,06/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0568-01U
Device Catalogue Number0684-00-0568-01U
Device Lot Number3000094740
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2019
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer08/07/2019
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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