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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Filling Problem (1233); Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2021
Event Type  malfunction  
Manufacturer Narrative
Additional reporter name: (b)(6), circulatory assistant manager. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the console generated gas gain, gas loss, and auto-fill failure alarms every few minutes. The console was swapped out, but this did not resolve the issue. Troubleshooting did not resolve the issue and a chest x-ray showed the iab was in the correct position. There was no visible blood in the tubing. The iab was removed and replaced. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, 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 Key12180406
MDR Text Key261935806
Report Number2248146-2021-00460
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
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 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0575
Device Lot Number3000132558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/16/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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