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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON(IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON(IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
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 03/06/2023
Event Type  Injury  
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) unit froze up.The system was rebooted and therapy was resumed, however, the patient had a drop in hemodynamics during and after the event.It was advised by the getinge representative to change to an alternate cardiosave iabp if available.The team was guided on how to transfer therapy to a different cardiosave with minimal downtime.Rn stated the patient had a drop in hemodynamics during and after the event.However, the patient is currently stable and hemodynamics have improved back to pre-event conditions.This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-01527.
 
Manufacturer Narrative
Additional contact person information - valerie nolan rn charge/ rose, rn.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint#: (b)(4).
 
Event Description
N/a.
 
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Brand Name
UNKNOWN INTRA-AORTIC BALLOON(IAB)
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key16622404
MDR Text Key312098275
Report Number2248146-2023-00211
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received06/14/2023
Supplement Dates FDA Received06/14/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Treatment
CARDIOSAVE / CH339488G1.
Patient Outcome(s) Other;
Patient Age67 YR
Patient SexMale
Patient Weight89 KG
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