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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 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
Type of investigation not yet determined: additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that the cs300 intra- aortic balloon pump (iabp) only works with batteries and it does not receive a load from the outside (ups or other). It is unknown if under which circumstances this event occurred or if there was patient involvement. However no adverse event was 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12631081
MDR Text Key276364708
Report Number2249723-2021-02347
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2011
Is the Device Single Use? No
Type of Device Usage Unkown

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