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 No Display/Image (1183)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that before use, the cs300 intra-aortic balloon pump (iabp) units display is blank.There was no patient involvement.

Manufacturer Narrative

Updated fields: h6 (type of investigation, investigation findings, component codes and investigation conclusions).Additional contact information: (b)(6).Getinge field service engineer (fse) able to reproduce the the issue and replaced video receiver pcb and cable.This corrected issue.Completed cs300 pm to factory specifications.Device passed all functional and safety tests according to factory specifications.No patient involvement.The failure analysis and testing dept.Received the following parts associated with this complaint video receiver pcb.The failure analysis and testing dept.Performed a visual inspection and found the parts to be in good condition.The failure analysis and testing dept.Installed video receiver pcb and video cable into the cs300 test fixture and tested the parts to factory specifications per the cs300 service manual.The fat performed the display test which passed testing.The fat could not replicate the failure the customer experienced of a blank display after running the cs300 for over one hour.Sending the video receiver board to the supplier.Part no longer able to be tested by the supplier.Investigation is complete.Retaining the part in the failure analysis and testing department.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• 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: 18314440
• MDR Text Key: 330466367
• Report Number: 2249723-2023-05280
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.