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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 Inability to Auto-Fill (1044)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and was able to reproduce the reported autofill failure. The fse also was able to verify the reported issue in the unit's logs. The fse discovered that the drive assembly was leaking and the unit had poor vacuum performance. To fix the issue, the fse replaced the drive manifold, 5000 hour maintenance kit. The fse also replaced the purge filter, as well as safety disk as its time had expired. The fse then completed a full calibration, and performed all 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 prior to use, the cs300 intra-aortic balloon pump (iabp) alarmed an autofill failure. There was no patient involvement, and no 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11096676
MDR Text Key226017602
Report Number2249723-2020-02250
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
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 Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2008
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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