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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-58
Device Problems Erratic or Intermittent Display (1182); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 12/20/2023
Event Type  malfunction  
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit screen looks bad.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, during start-up, the cs300 intra-aortic balloon pump (iabp) unit screen looks bad.
 
Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10, h11.Corrected fields: b5.A getinge field service engineer (fse) evaluated the unit for the reported malfunction.Fse was able to reproduce the reported issue.In order to resolve the issue, the lcd was replaced.All functional and safety checks were performed and the unit passed all tests performed.The unit was returned to the customer in good working conditions.
 
Manufacturer Narrative
Updated data: b4, e1 (initial reporter and email), e2, e3, g2, g3, g6, h2, h10.
 
Event Description
N/a.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi related data quality updates only. providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key18415922
MDR Text Key331582337
Report Number2249723-2023-05534
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108339
UDI-Public(01)10607567108339(21)SI104342I7
Combination Product (y/n)N
Reporter Country CodeSP
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 Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-58
Device Catalogue Number0998-00-3023-58
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received01/29/2024
03/26/2024
09/22/2024
Supplement Dates FDA Received02/06/2024
03/27/2024
09/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2007
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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