• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. The device will not be evaluated. The customer advised that the iabp did not fail. Device not returned to manufacturer.
 
Event Description
It was reported that an ap optical module failure occurred on a cs300 intra-aortic balloon pump (iabp) while it was in use on a patient. The fiber optics would not function correctly. The end user tried to connect to the patient but was unable to. The iabp was exchanged and the patient was then put on a 2nd cs300. The second cs300 was reported to alarm and display a maintenance code 53 (shuttle transducer offset failure). The second iabp was exchanged and the patient was then put on a third cs300 which was not reported to malfunction and therapy was provided. It was reported to the field service engineer, two days later during the iabp service visit, that the patient had expired the next day. The facility has indicated that they attribute the cause of death to surgical operation issues and that the patient's health was very bad. The facility has not reported that either of the pump failures contributed to the patient death. This report is for the third iabp used in the event with no reported failure. Reference our internal complaint number (b)(4) for this report and complaint numbers (b)(4) respectively for the first and second pumps used during this event which are being submitted on separate medical device reports.
 
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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10133004
MDR Text Key194479530
Report Number2249723-2020-00870
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0988-00-3023-53
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 Received07/30/2020
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: 06/09/2020 Patient Sequence Number: 1
Treatment
UNKNOWN IAB
-
-