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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Computer Operating System Problem (2898)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service representative also reported that the mainboard was broken, and that the customer does not want to repair the iabp, and that they will be replacing the iabp device next year with the successor model cardiosave.Additional information has been requested, and we will report accordingly if it becomes available.The full initial reporter name is (b)(6).
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) could not boot properly.The start up aborted after one second.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) could not boot properly.The start up aborted after one second.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
 
Manufacturer Narrative
The getinge field service engineer (fse) later reported that the customer changed their decision and wanted the iabp repaired.The fse reported that the issue was not the main board but the power supply being defective, and due to that, the batteries could not be charged and did not supply power to the iabp unit.The iabp unit attempted to power up while in battery mode, but shut off immediately after one second because of a short circuit in the power supply.To fix this issue, the fse replaced the power supply 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 to the customer and cleared for clinical service.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8108422
MDR Text Key128898228
Report Number2249723-2018-02061
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-61
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device AgeYR
Date Manufacturer Received12/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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