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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, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-62
Device Problem Device Contamination with Body Fluid (2317)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Type of investigation not yet determined : the customer has been presented with a quote for the cost estimate for repairs. Additional information is being requested with regards to the patient complication. Additionally, a report of user error was provided and we are seeking additional clarification. A supplemental report will be submitted upon completion of our investigation or if additional information is provided.
 
Event Description
It was reported by the customer that the cs300 intra-aortic balloon pump (iabp) unit had blood backed all the way through the tubing and potentially into the machine. It was reported that the patient had a complication that was not due to the cs300 device.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
Type of DeviceSYSTEM, 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13536784
MDR Text Key285637371
Report Number2249723-2022-00302
Device Sequence Number1
Product Code DSP
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
Type of Report Initial,Followup,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-62
Device Catalogue Number0998-00-3023-62
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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