• 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 UNKNOWN DATASCOPE INTRA-AORTIC BALLOON PUMP 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 UNKNOWN DATASCOPE INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Toxemia (2207)
Event Date 10/05/2020
Event Type  Death  
Manufacturer Narrative
There was no reported malfunction of the unit and neither the pump model or serial number was provided. However, additional information is being requested, and we will submit a supplemental report, if necessary. Not returned to manufacturer.
 
Event Description
An aortic valve replacement associated with pericardial patch (re-operation) was performed. A datascope trans ray plus 35cc intra-aortic balloon (iab) catheter was used along with an unknown datascope intra-aortic balloon pump (iabp) to provide iabp counterpulsation therapy as well. The surgery was completed successfully and iabp therapy was continued after the surgery. 3 days later, the iabp therapy was discontinued and the iab catheter was removed safely from the patient. The iab catheter was discarded in the hospital. It was reported that after removal of the of the iab catheter, the patient condition deteriorated and a positive reaction was observed for endotoxin shock the following morning. This report is for the unknown datascope intra-aortic balloon pump reported to be used in this event. There was no reported malfunction of the datascope intra-aortic balloon pump. The iab catheter will be reported in a separate mdr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN DATASCOPE INTRA-AORTIC BALLOON PUMP
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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10742361
MDR Text Key213418935
Report Number2249723-2020-01771
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
-
-