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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-55
Device Problem Gas Output Problem (1266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit with a system trainer where the reported issue was produced twice within the first 30 minutes. The fse tested the unit with a replacement safety disk and found that the safety disk was defective. The fse resolved the issue by replacing the safety disk which was a customer purchased part. The fse checked the unit in working mode for two hours, and performed functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. Upon completion of our investigation, a supplemental report will be submitted.
 
Event Description
It was reported that during a routine check, the cs100 intra-aortic balloon pump (iabp) alarmed leak in iab circuit. There was no patient involvement, and no adverse event reported.
 
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Brand NameCS100
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 Key12154715
MDR Text Key265591923
Report Number2249723-2021-01499
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031636
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,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3013-55
Device Catalogue Number0998-00-3013-55
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 Received09/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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