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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 Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported during a routine check performed by getinge representative, the cs300 intra-aortic balloon pump (iabp) failed electrical test fail #50.There was no patient involvement.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
Type of Device
SYSTEM, 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 Key15188371
MDR Text Key304916309
Report Number2249723-2022-01992
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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