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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Unexpected Shutdown (4019)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/21/2022
Event Type  malfunction  
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an unexpected shut down. There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had an unexpected shut down. There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.
 
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Brand NameCS300 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 Key13523480
MDR Text Key285545063
Report Number2249723-2022-00284
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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