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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 Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Occupation: supply chain mgr 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).
 
Event Description
It was reported that the customer could not aspirate two intra-aortic balloons (iab).It was noted that the iabs were able to be flushed.After removal, they tried to pull back on the iabs in saline and couldn¿t pull back.Ultimately, they ended up using a 40cc iab instead.There was no patient harm or adverse event reported.This report is for the 1st iab involved in this event.A separate report will be submitted for the 2nd iab.
 
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
It was reported that the customer could not aspirate two intra-aortic balloons (iab).It was noted that the iabs were able to be flushed.After removal, they tried to pull back on the iabs in saline and couldn¿t pull back.Ultimately, they ended up using a 40cc iab instead.There was no patient harm or adverse event reported.This report is for the 1st iab involved in this event.A separate report for the 2nd iab was submitted under mfg report number 2248146-2024-00077.
 
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Brand Name
SENSATION PLUS 8FR. 50CC 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 Key18652969
MDR Text Key334688900
Report Number2248146-2024-00074
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 Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0684-00-0575
Device Lot Number3000342795
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/09/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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