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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 Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 11/29/2017
Event Type  Death  
Manufacturer Narrative
A getinge field service engineer (fse) confirmed with the staff that the iabp alarmed "leak in iab circuit" and stopped inflating balloon during use. The fse then verified the alarm in the iabp logs, and was able to duplicate alarm during testing. The fse found that the iab fill connector on the side of the safety disk was partially tightened. He then tightened the connector and performed functional testing, as well as, safety check to factory specifications. The iabp passed all functional and safety checks was released for clinical use. There were no parts replaced.
 
Event Description
A customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped working, and multiple errors occurred. It was reported that the patient expired while obtaining a replacement iabp. It was not reported that the patient death was attributed to the iabp event.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. Additional information has been requested. A supplemental report will be sent upon receipt.
 
Event Description
A customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped working, and multiple errors occurred. It was reported that the patient expired while obtaining a replacement iabp. It was not reported that the patient death was attributed to the iabp event.
 
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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 Key7143967
MDR Text Key104291374
Report Number2249723-2017-01060
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 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/22/2017 Patient Sequence Number: 1
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