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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 0998-00-3023-55
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp and removed the drive assembly part and installed a new one for testing. The iabp device was operated for 30 minutes by connecting a test catheter balloon. The reported iabp device error was not observed. Functional tests and calibration of the iabp device was performed, and it was found that the iabp device passed all the tests. The date on which the device's safety disk needs to be changed cannot be read. Also, the defective drive assembly part must be replaced and installed with a new one. Additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) was giving electrical test failure 50&52. Fail from k6-k7-k8 tests. 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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12231776
MDR Text Key264596980
Report Number2249723-2021-01624
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Device Lot NumberN/A NOR REQUIRED FOR HARDWARE
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 Received07/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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