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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Display or Visual Feedback Problem (1184); Inflation Problem (1310)
Patient Problem Myocardial Infarction (1969)
Event Date 12/14/2018
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 after intra-aortic balloon (iab) insertion in an ami(acute myocardial infarction) the iab did not inflate. An alarm was generated, but the type of alarm is unknown. A new iab catheter was used to continue therapy. There was no reported injury to the patient.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8231126
MDR Text Key132535560
Report Number2248146-2019-00013
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000073087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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