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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-53
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp. The fse replaced the drive manifold and found the problem was the same. The fse checked the compressor unit and found that the diaphragm of compressor was damaged which was responsible for vacuum and pressure generation. To fix the issue, the 5000 hours maintenance kit must be replaced first. Further diagnosis could be done after replacement of the 5000 hours maintenance kit. 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 cs100 intra-aortic balloon pump (iabp) had a low vacuum error. It is unknown the circumstances under which the event occurred. It is also unknown if there was a patient involvement. However, there was no adverse event reported.
 
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Brand NameCS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12972558
MDR Text Key284524872
Report Number2249723-2021-02817
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3013-53
Device Catalogue Number0998-00-3013-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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