• 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. 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. CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problems Inability to Auto-Fill (1044); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2019
Event Type  malfunction  
Event Description
During the initial setup to the patient (urgent lhc for chest pain and ischemia on ekg), during the lhc procedure, the datascope cs300 iabp console failed to autofill the balloon. There was no harm or delay of care to the patient as a secondary iabp console was set up and used to autofill the balloon. The unit was tagged and picked up by our biomed department. The console was tested and they were able to duplicate the issue of not autofilling. Getinge service was contacted too and evaluated the unit and were able to replace the defective volume cylinder with post verified operation. The equipment was placed back in service. Manufacturer response for iabp console unit, datascope cs300 (per site reporter). Unknown if the territory manager was made aware. Getinge service was contacted and replaced defective part.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr
fairfield NJ 07004
MDR Report Key8703477
MDR Text Key148151984
Report Number8703477
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2019
Event Location No Information
Date Report to Manufacturer06/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-