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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0480-07
Device Problem Pressure Problem (3012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/03/2021
Event Type  Death  
Manufacturer Narrative
Complete event site name - (b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon(iab) therapy, the cardiosave intra-aortic balloon pump (iabp) generated no pressure source available alarm and was not showing the correct pressures. The getinge representative advised user to check inner lumen for any obstruction / clot /able to aspirate blood. User told everything seems to be ok , then it was advised to replace transducer. While replacing transducer user came to know that they forgot to open 3 way stop cock at patient end which has resulted this problem. As soon as they opened the 3 way stop cock and done zeroing , unit was found working properly. It was later reported on 06august2021 that the patient had expired on (b)(6) 2021. This report is for the iab. A separate report will be submitted for the cardiosave iabp.
 
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Brand NameLINEAR 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12379323
MDR Text Key268531402
Report Number2248146-2021-00555
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0480-07
Device Catalogue Number0684-00-0475
Device Lot Number3000119428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE / CB335613D1
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