MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that , the cs300 intra-aortic balloon pump (iabp) unit alarmed electrical test failure code #117.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, component codes , investigation conclusion), h10, h11.Corrected fields: h6 (health effect ¿ clinical code, health effect ¿ impact codes).Additional information: event site postal code: 12120, email: skornthip@yahoo.Co.Th.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced front end module pcb, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• Type of Device: SYSTEM, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 16003960
• MDR Text Key: 308404414
• Report Number: 2249723-2022-03198
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1