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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-UC-3013-67
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).
 
Event Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a display fault.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10877568
MDR Text Key218226710
Report Number2249723-2020-01987
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108681
UDI-Public10607567108681
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-UC-3013-67
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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