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

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; 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. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Failure of Device to Self-Test (2937)
Patient Problem Insufficient Information (4580)
Event Date 02/10/2023
Event Type  malfunction  
Event Description
It was reported that , the cs300 intra-aortic balloon pump (iabp) unit had a fiber optic test failure.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
It was reported that the cs300 intra-aortic balloon pump (iabp) fiber optic test fail.There was no information on patient involvement and patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Installed fiber optic parts (kit,fos lamp replacement) on unit preformed unit checkout.Unit passed all functional and safety testes.Cleared for clinical use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key16413392
MDR Text Key309989583
Report Number2249723-2023-01212
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
-
-