• 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 TRANS-RAY PLUS 7.5 FR. 40CC 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 CORP. - 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 Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Manufacturer Narrative
(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. (b)(4).
 
Event Description
It was reported that while inserting the intra-aortic balloon (iab), the iab could not be advanced to the appropriate placement. The iab was removed and replaced with a new one to successfully continue therapy. There was no patient harm or adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANS-RAY PLUS 7.5 FR. 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 Key13900641
MDR Text Key287891684
Report Number2248146-2022-00242
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0605
Device Lot Number3000130660
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/02/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
Treatment
UNKNOWN.
-
-