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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 0998-00-3023-53
Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  malfunction  
Event Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit has a distorted screen.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
Corrected data: b5, b6, b7, d10, h6(clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
 
Event Description
It was reported that during setup, the cs300 intra-aortic balloon pump (iabp) unit has a distorted screen.There was no patient involvement.
 
Manufacturer Narrative
Updated fields: h6 (type of investigation, investigation findings, component codes, investigation conclusions).Corrected fields: h6 (medical device - problem code).A getinge field service engineer (fse) went on-site to evaluate the reported issue.He could not duplicate the reported failure.There were no logs present reflecting the screen issue.As a precaution, the fse replaced the video receiver board, display controller board and video to receiver cable.The fse performed functional check and display test without issue.The device was returned to customer, after passing all functional testing.
 
Event Description
N/a.
 
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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 Key17758149
MDR Text Key323543233
Report Number2249723-2023-04076
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/20/2024
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 09/08/2023
Initial Date FDA Received09/15/2023
Supplement Dates Manufacturer Received10/10/2023
02/20/2024
Supplement Dates FDA Received10/11/2023
02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
N/A.; UNKNOWN.
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