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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. 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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2023
Event Type  malfunction  
Event Description
It was reported that every time the patient coughed, the cs300 intra-aortic balloon pump (iabp) unit had leak in circuit alarm.There was no patient harm.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use, the cs300 intra-aortic balloon pump (iabp) had a check iab catheter¿and a leak in iab circuit alarm every time the patient coughed.There was no patient harm reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit and could not duplicate any failure when tested with test balloon and patient simulator.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.
 
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, ENGLISH, 110V
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 Key18416684
MDR Text Key331598447
Report Number2249723-2023-05494
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public(01)10607567107882(21)SI154642C9
Combination Product (y/n)N
Reporter Country CodeUS
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 09/19/2024
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 Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received12/29/2023
Supplement Dates Manufacturer Received03/01/2024
09/19/2024
Supplement Dates FDA Received03/01/2024
09/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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