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

Model Number 0998-00-3023-53

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) was alarming electrical test fails code #39.There was no patient involvement.

Manufacturer Narrative

The stm performed a visual inspection of the iabp unit and observed that the main board had a saline spill going all the way down the board with some corrosion on several of the electrical components.The stm noted that the fault code generated was caused by the saline spill.The stm removed and replaced the main bard then completed pm service.In addition, the batteries were replaced per customer approval.The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, 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: 16236589
• MDR Text Key: 308872210
• Report Number: 2249723-2023-00414
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1