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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 Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Respiratory Distress (2045)
Event Date 11/10/2017
Event Type  Death  
Manufacturer Narrative
A getinge service territory manager (stm) evaluated the iabp and reported that the iabp was put to run on batteries with trainer and balloon and the battery alarmed at 50 minutes, which indicates a run time test failure. To resolve the issue, the stm replaced the batteries. The iabp passed all functional and safety tests per factory specifications and was returned to customer and cleared for clinical use.
 
Event Description
The customer reported that during use, the cs300 intra-aortic balloon pump (iabp) shut down when the a/c power cord was disconnected from the wall to get ready for transport. The nurses denied disconnecting the batteries and stated that no alarms or messages were activated. No adverse event was reported at this time. Subsequently, the customer advised several days later that the patient expired and that the cause of death was due to respiratory status, and not related or attributed to the iabp.
 
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. At this time, the customer has not requested getinge to evaluate the iabp. If additional information is made available, a supplemental report will be sent.
 
Event Description
The customer reported that during use, the cs300 intra-aortic balloon pump (iabp) shut down when the a/c power cord was disconnected from the wall to get ready for transport. The nurses denied disconnecting the batteries and stated that no alarms or messages were activated. No adverse event was reported at this time. Subsequently, the customer advised several days later that the patient expired and that the cause of death was due to respiratory status, and not related or attributed to the iabp.
 
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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 Key7095257
MDR Text Key104095625
Report Number2249723-2017-00949
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 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
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 Received11/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2009
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: 12/07/2017 Patient Sequence Number: 1
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