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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, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3013-53
Device Problem No Display/Image (1183)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) units display screen is black.
 
Manufacturer Narrative
Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5,b6,b7,d10,h6(clinical & impact).
 
Event Description
It was reported that before use, the cs300 intra-aortic balloon pump (iabp) units display screen is black.There was no patient involvement.
 
Event Description
N/a.
 
Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10, h11 corrected fields: d1, d3.A getinge field service engineer (fse) checked the unit and to fix the issue he replaced the video receiver pcb.The fse then completed pm with full calibration, functional testing and safety check to factory specifications.The unit was then returned to the customer and cleared for customer use.
 
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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. - 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 Key17692238
MDR Text Key322756332
Report Number2249723-2023-03944
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/28/2023
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 Number0998-00-3013-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received10/02/2023
12/28/2023
Supplement Dates FDA Received10/03/2023
01/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2005
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.; UNKNOWN.
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