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; 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; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-53
Device Problem Failure to Power Up (1476)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse spoke via telephone with the customer and confirmed the issue was due to a problem with the 220 v plug.The plug was changed and the issue resolved.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) would not switch on.It is unknown under which circumstances this event occurred.There was no patient involvement, and no adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11339327
MDR Text Key232339464
Report Number2249723-2021-00319
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567107882
UDI-Public10607567107882
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/27/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received04/23/2021
Supplement Dates FDA Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-