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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-53
Device Problem Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse noted that the iabp unit would make a slight click when the switch was turned on.The fse narrowed the issue down to a shorted solenoid driver board.The fse replaced the solenoid driver board then complete all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) would not power on.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) would not power on.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11382908
MDR Text Key234221227
Report Number2249723-2021-00458
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 company representative,user f
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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