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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, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-55
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device (10/213): a getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp) unit. The fse was also able to verify that the power supply was defective. To fix these issues the fse replaced the power supply, he then performed functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) would not power on. There was no patient involvement, and no adverse event reported.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
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 Key13051866
MDR Text Key282629594
Report Number2249723-2021-02918
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-55
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Unkown

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