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

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/15/2021
Event Type  Death  
Manufacturer Narrative
Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate the iabp. The fse arrived on site and checked the logs and did not see any faults or errors. The fse then connected the test catheter and patient simulator and ran the unit for one hour without any issues. Unit passed all calibrations, functional and safety test performed. The iabp was returned for the customer and cleared for clinical use. A supplemental report will be submitted upon completion of our evaluation. The associated intra-aortic balloon (iab) involved in this event has been reported under medwatch report # 2248146-2022-00012. Initial reporter full name: (b)(6).
 
Event Description
It was reported that the patient expired while connected to the cs300 intra-aortic balloon pump (iabp). Patient death while in use. It was later reported that the customer does not believe the iabp unit malfunctioned and had requested that the iabp unit have a functional check performed to ensure the iabp unit is operating correctly.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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 Key13236646
MDR Text Key283675569
Report Number2249723-2022-00062
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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