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

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB 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 FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) there was an "unable to calibrate iab optical sensor" alarm generated. The customer tried to calibrate once pulse pressure was adequate but it was unsuccessful. The fiber optic cable was disconnected and reconnected, but that did not resolve the problem. The central lumen was transduced. There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) there was an "unable to calibrate iab optical sensor" alarm generated. The customer tried to calibrate once pulse pressure was adequate but it was unsuccessful. The fiber optic cable was disconnected and reconnected, but that did not resolve the problem. The central lumen was transduced. There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: device available for evaluation: [from]: yes, [to]: no. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8209438
MDR Text Key131918503
Report Number2248146-2019-00001
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 03/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/10/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000081750
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-