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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 Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2017
Event Type  malfunction  
Event Description
It was reported that the screen of the cs300 intra-aortic balloon pump (iabp) went blank, while in use on a patient. The iabp was still pumping when the screen went black. The iabp was replaced with another cs300 without problems. There was no serious injury or adverse event reported.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. The getinge service territory evaluated the iabp and confirmed that the screen was working intermittently. The stm re-seated all connections on display and tested. No further issues found. Cs300 iabp pm services completed. Full pm, safety, calibration, and functionality checks passed factory specifications. Returned to clinical service upon completion.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a monitor related issue. No patient involvement or adverse event was reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7187715
MDR Text Key104064182
Report Number2249723-2018-00065
Device Sequence Number1
Product Code DSP
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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