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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 Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint record id # (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), a different sheath was used because there was no sheath included in the iab packaging. 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 Key11081442
MDR Text Key227356109
Report Number2248146-2020-00688
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
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
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 Number3000118913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2020
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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