• 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 MEGA 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 CORP. - FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-01
Device Problems Inability to Auto-Fill (1044); Inflation Problem (1310)
Patient Problem Ischemia (1942)
Event Date 05/22/2021
Event Type  Injury  
Manufacturer Narrative
Complete event site name: nasser institute for research and treatment the device will not be returned to the manufacturer so we are unable to complete an evaluation. Customer indicated that the device was not kept for evaluation. If additional information becomes available, we will send a supplemental report. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-balloon (iab) therapy, an auto-fill failure occurred and the iab would not inflate. This caused ischemia in the patient's leg and it is related to his general condition. The customer states that the complication was technical and due to how the surgeon inserted the iab.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEGA 8FR. 50CC 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 Key12048535
MDR Text Key257712616
Report Number2248146-2021-00403
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot NumberUNKNOWN
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 Received11/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/23/2021 Patient Sequence Number: 1
-
-