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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Loss of consciousness (2418)
Event Date 02/12/2017
Event Type  Injury  
Manufacturer Narrative
The device history record (dhr) for the iabp involved in the event was reviewed. There were no non-conformances noted in the dhr related to the reported event.
 
Event Description
It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present. Tried plugging fiber optic into a different iabp machine and no ao waveform was present. Further, it was reported the customer is not attributing the adverse event (i. E. Patient death) to the device. This is 2 of 2 reports for the same event.
 
Manufacturer Narrative
The company account manager for this facility reported that there was no malfunction of the pump at the time of the event, and it performed perfectly. Further, the said representative reported that the only issue was with the iab catheter, and that issue was with specifically the fiber optic sensor on the iab catheter. A separate report was submitted under medwatch #2248146-2017-00025 addressing this alleged iab malfunction.
 
Event Description
It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present. Tried plugging fiber optic into a different iabp machine and no ao waveform was present. Further, it was reported the customer is not attributing the adverse event (i. E. Patient death) to the device. This is 2 of 2 reports for the same event.
 
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Brand NameCARDIOSAVE
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 Key6465562
MDR Text Key72062016
Report Number2249723-2017-00018
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-53
Other Device ID NumberCH246496L6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/13/2016
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: 04/06/2017 Patient Sequence Number: 1
Treatment
SENSATION PLUS 7.5FR. 40CC IAB.
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