MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-83

Device Problems Erratic or Intermittent Display (1182); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that , the cs300 intra-aortic balloon pump (iabp) unit has a high drive pressure detected, display is intermittently is blank/dark.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10, h11.Corrected fields: d5, e2, e3, g2.Additional information: (email - (b)(6)).A getinge field service engineer (fse) confirmed high drive pressure error in logs.One occurrence of the issue present.Ran unit at 120 bpm.Could not duplicate error.Customer also reported a maintenance code 3.Error code is a minor fault per service manual description of fault.Could not duplicate fault code.Display had intermittent flickering.Replaced video receiver board and associated cable.Could not duplicate display issue.Performed a full function and calibration check.Device operating up to manufacturers specifications.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V
• 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: 17342395
• MDR Text Key: 319205443
• Report Number: 2249723-2023-03220
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108285
• UDI-Public: 10607567108285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-83
• Device Catalogue Number: 0998-00-3023-83
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1