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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 Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The getinge field service engineer (fse) that encountered the issue replaced the batteries and completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery run time test.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 Key11069446
MDR Text Key224598446
Report Number2249723-2020-02237
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
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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