Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medsun Reports
  • 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
 

Back to search results
Type of Device:
system, balloon, intra-aortic and control
Device Brand Name:
CS300 IABP With Intellisense
Device Manufacturer's Name:
Datascope Corp.
Date of this Report:
(mm/dd/yyyy)
10/21/2014
Describe the Event
or Problem:
Fiberoptic CS300 intraaortic balloon pump (IABP) malfunctioned and the fiberoptic portion of IABP failed. Mean pressures on the IABP were reading much higher than the systolic pressures. IABP converted from fiberoptic to a conventional IABP.
the device(s) may have
caused or contributed to:
Potential for patient harm
New Search
-
-