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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 Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2022
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device|10: a getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp) unit and was able to reproduce the reported issue. The fse determined that the power supply was defective. To fix the issue, the fse replaced the power supply, and performed all functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported by the customer that during a routine check the cs300 intra- aortic balloon pump (iabp) unit will not power on. There was no patient involvement, and no adverse event reported.
 
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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 Key13548768
MDR Text Key285741604
Report Number2249723-2022-00316
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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