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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 Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
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 during insertion of the intra-aortic balloon (iab), the balloon unfurled during insertion. There was no reported injury to the patient.
 
Event Description
It was reported during insertion of the intra-aortic balloon(iab), the balloon unfurled during insertion. There was no reported injury to the patient.
 
Manufacturer Narrative
Product available for eval from: yes to: no (udi) # (b)(4). The device has not been returned to the manufacturer so we are unable to complete an evaluation. We are unable to confirm the reported event. If additional information is provided we will send a supplemental report with our additional findings. (b)(4).
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10387208
MDR Text Key202425363
Report Number2248146-2020-00419
Device Sequence Number1
Product Code DSP
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 08/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0575
Device Lot Number3000115025
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No

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