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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/08/2021
Event Type  Death  
Manufacturer Narrative
At the customer's request, a getinge service territory manager (stm) was dispatched to investigate. The stm evaluated the iabp unit and observed alarms for "gas loss" and "triggering issues. " the stm performed a complete preventative maintenance (pm) service and ran all functional tests and validated calibration. No issues were found and the iabp unit was cleared for use and returned to the customer. The first name of the initial reporter has been abbreviated due to field character limit; the full name should read (b)(6). The full name of the event site was shortened due to field character limit; the full name is (b)(6) medical center.
 
Event Description
The customer has requested that the cardiosave intra-aortic balloon pump (iabp) be checked to verify it can run and work properly after it was reported that the intra-aortic balloon (iab) had burst. It was noted that patient therapy was emergently initiated in an attempt to save the patient; however, the patient expired. There was no reported malfunction of the iabp unit involved in this event, and the customer has not attributed the patient death to the iabp unit involved. This report is for the iabp used in the event. The iab is being reported on a separate mdr.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12101266
MDR Text Key260021460
Report Number2249723-2021-01416
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2014
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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