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 Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit has a distorted screen.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, h6(clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.

Event Description

It was reported that during setup, the cs300 intra-aortic balloon pump (iabp) unit has a distorted screen.There was no patient involvement.

Manufacturer Narrative

Updated fields: h6 (type of investigation, investigation findings, component codes, investigation conclusions).Corrected fields: h6 (medical device - problem code).A getinge field service engineer (fse) went on-site to evaluate the reported issue.He could not duplicate the reported failure.There were no logs present reflecting the screen issue.As a precaution, the fse replaced the video receiver board, display controller board and video to receiver cable.The fse performed functional check and display test without issue.The device was returned to customer, after passing all functional testing.

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: 17758149
• MDR Text Key: 323543233
• Report Number: 2249723-2023-04076
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/10/2023; 02/20/2024
• Supplement Dates FDA Received: 10/11/2023; 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.