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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter restriction alarm as the iab began to autofill.The iab tried to fill again, but the same alarm was generated.The iab was removed and replaced with a new one, but the same alarm occurred again.The customer then swapped out the console and the iab worked normally.Therapy was completed the following day.This report is for the 2nd iab used in this event.A separate report will be submitted for the 1st iab used.
 
Manufacturer Narrative
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.Reference complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter restriction alarm as the iab began to autofill.The iab tried to fill again, but the same alarm was generated.The iab was removed and replaced with a new one, but the same alarm occurred again.The customer then swapped out the console and the iab worked normally.Therapy was completed the following day.This report is for the 2nd iab used in this event.A separate report will be submitted for the 1st iab used.
 
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Brand Name
SENSATION PLUS 8 FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10655211
MDR Text Key210590743
Report Number2248146-2020-00532
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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