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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 Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
It was reported that prior to use the cs300 intra- aortic balloon pump (iabp) unit displayed iab disconnected error.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Testing of actual/suspected device: the getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp) unit and observed the unit displaying iab disconnected error.To fix the issue, the fse replaced the k6a vent valve, 24 vdc, 2-way no.Which caused the error and code 66 in the logs.The fse performed 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.
 
Manufacturer Narrative
Testing of actual/suspected device: the getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp) unit and observed the unit displaying iab disconnected error.To fix the issue, the fse replaced the k6a vent valve, 24 vdc, 2-way no.Which caused the error and code 66 in the logs.The fse performed 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 that prior to use the cs300 intra- aortic balloon pump (iabp) unit displayed iab disconnected error.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
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 Key12899326
MDR Text Key285394098
Report Number2249723-2021-02767
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
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
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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 Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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