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

Model Number 0998-00-3023-65

Device Problem No Display/Image (1183)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that during patient use, the cs300 intra-aortic balloon pump (iabp) unit's screen blackout.

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the cs300 intra-aortic balloon pump (iabp) unit's screen blackout.There was no patient harm.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.A getinge field service engineer (fse) evaluated the unit and was able to reproduce the reported failure.To fix the issue, the fse replaced the display with a unused display the hospital had.3 gfes attempts were made to get status on the unit and no information was provided.If further information is provided, the complaint will be reopened and update accordingly.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: 17497326
• MDR Text Key: 320760950
• Report Number: 2249723-2023-03610
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: 10607567108322
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

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: Health Professional
• Device Model Number: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 12/18/2023
• Supplement Dates FDA Received: 09/01/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1