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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/15/2021
Event Type  Death  
Manufacturer Narrative
Complete reporter 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). Device not returned.
 
Event Description
It was reported that the patient had expired while connected to the cs300 intra-aortic balloon pump (iabp). Customer did not believe the device malfunctioned. This report is for the iab. A separate report will be submitted for the cs300 intra-aortic balloon pump (iabp).
 
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Brand NameUNKNOWN INTRA-AORTIC BALLOON
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 Key13169372
MDR Text Key283255029
Report Number2248146-2022-00012
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 Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/31/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
Treatment
CS300 / SI149669L8
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