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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 Optical Problem (3001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2020
Event Type  malfunction  
Manufacturer Narrative
Additional initial reporter name: (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).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm. The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed. The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION PLUS 8 FR. 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key11101291
MDR Text Key228037885
Report Number2248146-2020-00704
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000115025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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