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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-55
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during pre use check, the cs300 intra-aortic balloon pump (iabp) helium tank leaking.There was no patient involvement.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate the issue and found that it was gasket issue.The unit was replaced with a new gasket by the fse.The unit is ok.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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 Key18649462
MDR Text Key334625834
Report Number2249723-2024-00467
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSN
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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