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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
Catalog Number 0998-00-3023-55
Device Problems Inability to Auto-Fill (1044); Output below Specifications (3004)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The distributor's getinge trained field service engineer (fse) was dispatched to evaluate this unit. The fse was able to reproduce the issue and noted that the customer did not perform preventative maintenance (pm) regularly on the iabp unit involved in this event. The last pm was noted to have been performed over five years ago. The fse replaced the 5000 hour maintenance kit, safety disk, batteries and o-rings for the drive assembly then performed all calibrations as per the service manual. It was noted that all pneumatic performance tests gave acceptable values. The iabp unit was tested using a system trainer and maquet test balloon for more than fifteen minutes without issue. Subsequently, the fse 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 prior to use, the cs300 intra-aortic balloon pump (iabp) generated a autofill failure alarm and low vacuum alarm intermittently. 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 Key10928597
MDR Text Key218994844
Report Number2249723-2020-02043
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSY
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2011
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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