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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-UC-3013-53
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the power supply assembly and the issue was rectified.The iabp is working properly.
 
Event Description
It was reported that, prior to use, the cs100 intra-aortic balloon pump (iabp) was not working on mains.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that, prior to use, the cs100 intra-aortic balloon pump (iabp) was not working on mains.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
The fse confirmed the unit was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that, prior to use, the cs100 intra-aortic balloon pump (iabp) was not working on mains.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10637499
MDR Text Key210181123
Report Number2249723-2020-01629
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107745
UDI-Public10607567107745
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-UC-3013-53
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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