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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 Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date. It was reported by a getinge field service engineer (fse), that the fse contacted the customer and they reported that they were able to remedy this fault on their own, and the iabp unit has been placed back into clinical use.
 
Event Description
The customer reported that after they were running through functional tests on the cs300 intra-aortic balloon pump (iabp) due to a safety disk replacement, during the safety disk leak test the iabp unit would not recognize the safety disk. The customer tried other test and the iabp unit would not respond. The unit recently had the field actions applied by (b)(4) technician representative. There was no patient involvement, and there was no adverse event reported.
 
Manufacturer Narrative
The customer stated that after replacing batteries this unit became fully functional.
 
Event Description
The customer reported that after they were running through functional tests on the cs300 intra-aortic balloon pump (iabp) due to a safety disk replacement, during the safety disk leak test the iabp unit would not recognize the safety disk. The customer tried other test and the iabp unit would not respond. The unit recently had the field actions applied by uhs technician representative. There was no patient involvement, and there was no adverse event 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 Key7768840
MDR Text Key117012804
Report Number2249723-2018-01348
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2010
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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