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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 Inaccurate Synchronization (1609)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has cancelled their request for getinge to evaluate the iabp unit involved in this event.The customer has reported that the iabp unit is working properly.(b)(6); not returned to manufacturer.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an intra-aortic balloon (iab)that did not inflate at the correct time.There was no patient harm, and no adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an intra-aortic balloon (iab)that did not inflate at the correct time.There was no patient harm and no adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an intra-aortic balloon (iab)that did not inflate at the correct time.There was no patient harm and no adverse event was 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 Key10920432
MDR Text Key218993585
Report Number2249723-2020-02034
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,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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