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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problem Filling Problem (1233)
Patient Problem Death (1802)
Event Date 06/20/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).(b)(6).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).Device not returned.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm.The customer changed the helium bottle but the alarm continued.Customer changed the console but same alarm was generated.A new balloon was inserted.It was reported that the patient expired.This report is for the first iab used.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm.The customer changed the helium bottle but the alarm continued.Customer changed the console but same alarm was generated.A new balloon was inserted.It was reported that the patient expired.This report is for the first iab used.
 
Manufacturer Narrative
No decon or visual inspection of product performed since product was not returned.The product was not returned and so could not be evaluated.An evaluation of the pictures provided by the customer confirm the "autofill failure" alarm.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event reference complaint (b)(4).Device not returned.
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8803899
MDR Text Key151476657
Report Number2248146-2019-00608
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/26/2019
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? Yes
Device Operator Health Professional
Device Expiration Date04/06/2020
Device Catalogue Number0684-00-0433
Device Lot Number3000049084
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/18/2019
Supplement Dates Manufacturer Received07/24/2019
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age75 YR
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