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 Break (1069)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a broken screen.

Event Description

It was reported that prior to use during daily checks, the cs300 intra-aortic balloon pump (iabp) had a broken screen.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, component code, investigation conclusion), h10.Additional information: e1 (event site telephone: (b)(6)).It was reported that the cs300 intra-aortic balloon pump (iabp) had broken screen and screen was flickering.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He confirmed the issue and found one of the connectors in the monitor had come loose.After securing the connector properly, fse performed a pm, full calibration, and tested the unit.The product passed all functional/safety testing.Returned the unit to the customer.Batteries were replaced due to scheduled maintenance.

• 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: 18866833
• MDR Text Key: 337372248
• Report Number: 2249723-2024-00977
• 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: 05/20/2024

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
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 05/17/2024
• Supplement Dates FDA Received: 03/18/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1