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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-64
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, during a maintenance plan the cs300 intra-aortic balloon pump (iabp) switch is a little hard and the counter-pulse does not start.There was no patient involvement reported.
 
Manufacturer Narrative
Updated fields: b4, d9(device available for eval), (investigation type, investigation findings & investigation conclusions).A getinge field service engineer (fse) evaluated unit.The switch was a little hard and the counterpulse does not start.Dissassembled and cleaned with contactless cleaner.Reassembly ok.The switch no longer blocking and the counter-pulse starts normally.All functional and safety checks been performed to meet factory specifications.
 
Event Description
N/a.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key18355896
MDR Text Key331204681
Report Number2249723-2023-05341
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108308
UDI-Public10607567108308
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-64
Device Catalogue Number0998-00-3023-64
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received12/19/2023
Supplement Dates Manufacturer Received03/24/2024
Supplement Dates FDA Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2007
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.
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