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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-XX
Device Problem Pumping Stopped (1503)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ventricular Fibrillation (2130)
Event Date 02/10/2018
Event Type  Death  
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, and we will report accordingly if it becomes available.
 
Event Description
It was reported that while delivering intra-aortic balloon pump therapy with a cs300 to a patient, the patient coded and went into ventricular fibrillation. During this event, the iabp lost ecg trigger and stopped pumping. The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service. No specific issue with iabp was cited. The patient's death is not being attributed to the iabp.
 
Manufacturer Narrative
Corrected: (catalog number to 0998-00-0800-xx and (b)(4)). A getinge (b)(4) (stm) evaluated the iabp and found no problem during his inspection. The iabp passed all functional and safety tests to factory specifications, returned to customer and cleared for clinical use.
 
Event Description
It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation. During this event, the iabp lost ecg trigger and stopped pumping. The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service. No specific issue with iabp was cited. The patient's death is not being attributed to the iabp.
 
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.
 
Event Description
It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation. During this event, the iabp lost ecg trigger and stopped pumping. The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service. No specific issue with iabp was cited. The patient's death is not being attributed to the iabp.
 
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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 Key7328523
MDR Text Key102063427
Report Number2249723-2018-00389
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 07/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-XX
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 Received07/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2012
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: 03/09/2018 Patient Sequence Number: 1
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