• 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
Model Number N/A
Device Problem Output below Specifications (3004)
Patient Problem No Patient Involvement (2645)
Event Date 03/18/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. A getinge service territory manager (stm) evaluated the unit and determined there was a vacuum leak in the drive manifold. To resolve the issue, the stm replaced the drive manifold. Unrelated to the reported issue, the stm found concealment labels to be missing and installed new concealment labels. The iabp passed all functional, and safety checks to factory specifications. The unit was returned to the customer and cleared for clinical use.
 
Event Description
It was reported by the customer that the cs300 intra-aortic balloon pump (iabp) displayed a low vacuum alarm. It is unknown under which circumstances this event occurred; however there was no patient involvement, thus no adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9943738
MDR Text Key187114963
Report Number2249723-2020-00596
Device Sequence Number1
Product Code DSP
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 04/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-