• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 04/04/2021
Event Type  Death  
Manufacturer Narrative
No malfunction reported for this iabp. A supplemental report will be submitted upon receipt of additional information. Not returned to the manufacturer.
 
Event Description
Received a call from the icu manager at (b)(6) medical center in (b)(6) regarding an event that occurred with a patient on the cs300. She explained the situation verbatim from what her staff reported. (b)(6) yo male had emergency cabg surgery on the evening of (b)(6) 2021, came to the icu on a iabp. During the early hours of (b)(6) 2021 the pump started alarming and they found that the port fill tubing on the safety disk had broken off. They started manual inflation until another pump was brought to the icu, hooked up the patient to the new pump and continued with therapy. The patient expired later in the day on (b)(6) 2021. This complaint is for the second iabp used. This report is for the second cs300 iabp. The first iabp has been reported separately under medwatch 2249723-2021-00917 and the intra-aortic balloon catheter used in this event has been reported separately.
 
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. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11791419
MDR Text Key249503878
Report Number2249723-2021-00970
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K63525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/07/2021 Patient Sequence Number: 1
Treatment
INTRA-AORTIC BALLOON CATHETER
-
-