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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300; 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 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
Device not accessible for testing: additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during patient use the cs300 intra-aortic balloon pump (iabp) had a power failure.No patient harm, serious injury or adverse event was reported.
 
Event Description
N/a.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the solenoid driver board, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released for cleared for clinical service.
 
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Brand Name
CS300
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 Key12393749
MDR Text Key268997081
Report Number2249723-2021-01970
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567112541
UDI-Public10607567112541
Combination Product (y/n)N
Reporter Country CodeEI
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
Report Date 02/19/2024
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 Number0998-00-3023-55
Device Catalogue Number0998-00-3023-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received08/31/2021
Supplement Dates Manufacturer Received01/17/2022
02/17/2024
Supplement Dates FDA Received02/09/2022
02/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2010
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNKNOWN.
Patient SexPrefer Not To Disclose
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