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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 Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to investigate. The stm evaluated the iabp unit but was unable to duplicate the customer's reported issue. Upon review of the iabp log files, the stm observed fault code #64 logged once. As per the service manual, the stm cleaned the power supply fan then powered on the iabp unit several times without issue. Subsequently, the stm completed 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 during use on a patient in the intensive care unit (icu), the cs300 intra-aortic balloon pump (iabp) generated a system 7 malfunction. It was later clarified that the customer had observed a maintenance required code #7. The iabp unit was swapped out with another iabp unit. There was no patient harm, serious injury or adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10479544
MDR Text Key205260308
Report Number2249723-2020-01404
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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