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

MAUDE Adverse Event Report: MAQUET GETINGE GROUP/ DATASCOPE CORP. SENSATION PLUS 7.5 FR. 40CC FIBER-OPTIC IAB CA 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
 

MAQUET GETINGE GROUP/ DATASCOPE CORP. SENSATION PLUS 7.5 FR. 40CC FIBER-OPTIC IAB CA SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number 30000675260470
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2019
Event Type  Injury  
Event Description
Suspected iab rupture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENSATION PLUS 7.5 FR. 40CC FIBER-OPTIC IAB CA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET GETINGE GROUP/ DATASCOPE CORP.
45 barbour pond drive
wayne NJ 07470
MDR Report Key9284680
MDR Text Key165385451
Report NumberMW5090884
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number30000675260470
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/05/2019 Patient Sequence Number: 1
-
-