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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-53
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) would not switch on. There was no patient involvement, and no adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, 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 Key10662269
MDR Text Key211501533
Report Number2249723-2020-01655
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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