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 Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) unit displayed an electrical test fails code 52 while the customer attempted to start up device.There was no patient involved reported.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected fields: d5, e3, h6 (medical device ¿ problem code).A getinge field service engineer (fse) evaluated the unit and found that unit had electrical fail fault #52 in logs.History shows drive manifold and drive transducer were just replaced.To fix this issue fse replaced front end board.Unit passed complete pm with full calibration, functional, and electrical safety tests to factory specifications.Unit is cleared for clinical use and returned to customer.

• 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: 16496107
• MDR Text Key: 310812963
• Report Number: 2249723-2023-01402
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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: Biomedical Engineer
• 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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1