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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
Model Number N/A
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.Upon initial inspection, the fse verified the reported issue, however, then found that the speaker had unplugged from the circuit board.The fse resolved the issue by plugging the speaker back in.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that during customer in-service training, the cs300 intra-aortic balloon pump (iabp) alarm was not sounding, despite pressing the button.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that during customer in-service training, the cs300 intra-aortic balloon pump (iabp) alarm was not sounding, despite pressing the button.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
MDR Report Key11657166
MDR Text Key245180420
Report Number2249723-2021-00768
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,health
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/08/2021
Patient Sequence Number1
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