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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problems Inability to Auto-Fill (1044); Inappropriate Waveform (2536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: (b)(6). Complete initial reporter name: (b)(6). Additional 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 an auto-fill failure alarm that would not resolve with basic troubleshooting. The catheter tip position was verified via chest x-ray. The console was swapped out for a different one, but this did not resolve the issue. After changing the console, it immediately generated a leak in iab circuit alarm. The bedside nurse performed an iab fill and reduced the augmentation setting by two bars which allowed the pump to restart. The patient was alert and oriented but moving a great deal per the nurse. It was noted that the alarm was consistent with patient movement. A screenshot of the console monitor revealed an unreliable electrocardiogram (ecg) waveform, the console switching back and forth between ecg and pressure triggers, as well as round/flattened balloon waveform peaks. The nurse removed and replaced the ecg patches and added a touch of doppler gel which corrected ecg waveform and trigger issues. The iab was then removed and replaced successfully. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12533346
MDR Text Key273359287
Report Number2248146-2021-00630
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
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 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000138016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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