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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01
Device Problems Restricted Flow rate (1248); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2021
Event Type  malfunction  
Manufacturer Narrative
Occupation: administrator / supervisor, bsn, rn, interim team leader. The device will not be 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).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab became kinked and the console generated a catheter restriction alarm. The patient was later transferred to another facility with the iab still inserted. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC 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
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11900398
MDR Text Key253136421
Report Number2248146-2021-00338
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
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 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2021
Device Model Number0684-00-0568-01
Device Catalogue Number0684-00-0567
Device Lot Number3000083930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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