• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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. Complaint record id # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, the balloon catheter didn't work. There was no reported injury to the patient.
 
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. Complaint record # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, the balloon catheter didn't work. There was no reported injury to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENSATION PLUS 8FR. 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9665730
MDR Text Key187910635
Report Number2248146-2020-00072
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 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0575
Device Lot Number3000105516
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No

-
-