• 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 CS100 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 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-UC-3013-65
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue. The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that while in use on a patient the iab catheter on a cs100 intra-aortic balloon pump (iabp) rupture. There was no harm or injury to patient and no adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS100
Type of DeviceSYSTEM, 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12146959
MDR Text Key265568892
Report Number2249723-2021-01483
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-UC-3013-65
Device Catalogue Number0998-UC-3013-65
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

-
-