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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS100 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3013-XX
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem Death (1802)
Event Date 08/18/2016
Event Type  Death  
Manufacturer Narrative
The unit was evaluated by both the company field service engineer (fse) and the customer service representative. A review of the fault logs revealed there were no errors related to the event. It was also reported the issue with the iabp console appeared to have been with the on/off switch (p/n 0012-00-0834) and which was replaced. Further, it was also reported the batteries utilized by the customer are non-maquet batteries. A test of the batteries revealed they would fail the run time test. The batteries were replaced as well. The unit was safety and functional tested. All tests revealed the unit met specifications. The manufacturer is requesting the on/off switch (p/n 0012-00-0834) to be returned for further evaluation.
 
Event Description
Customer reported: iabp console shut down unexpectedly twice during use/therapy. It was also reported, the iabp console and catheter were replaced after patient received emergency surgery. In addition, the customer is not attributing the patient death to the device.
 
Manufacturer Narrative
The device history record (dhr) for the iabp involved in the event was reviewed. There were no nonconformances noted in the dhr related to the reported event. Further, it was reported by the customer there would be no patient information available per their policy and the replaced power on/off switch (p/n 0012-00-0834) has been discarded. No further investigation can be performed. Updated: date received by mfr, type of reports, if follow-up, what type?, evaluation codes, additional mfr narrative.
 
Event Description
Customer reported: iabp console shut down unexpectedly twice during use/therapy. It was also reported, the iabp console and catheter were replaced after patient received emergency surgery. In addition, the customer is not attributing the patient death to the device.
 
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Brand NameCS100 INTRA-AORTIC BALLOON PUMP
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 Key5961598
MDR Text Key55096638
Report Number2249723-2016-00027
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-3013-XX
Other Device ID NumberSA02777-G4
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 Received09/20/2016
Was Device Evaluated by Manufacturer? Yes
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: 09/19/2016 Patient Sequence Number: 1
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