MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that 2 hours after starting treatment, the cardiosave intra-aortic balloon pump (iabp) unit had an internal communication error.Pci of acs patient was performed.Pci was completed, and since blood pressure was low (sys 70-80), iabp was administered and the patient returned to the icu.Suddenly the iabp monitor waveform becomes flat in the icu.After a while, a continuous alarm sounds and "internal communication error has occurred" is displayed.Only nurses were available, so biomed engineer was contacted, but the situation did not improve.The biomed engineer connected to cs300 and resumes driving.Currently, the patient is conscious, and there are currently no health hazards.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, component codes, investigation conclusion), h10.Additional information: event postal code: (b)(6).A getinge field service engineer inspected the iabp unit at service center after returning from the facility.An attempt was made to boot-up of this iabp unit, but the unit kept loading and it ended up in failure.There were no failure codes recorded in the event log file of this iabp unit.Although the display was replaced, the issue was not resolved.When the executive processor board was replaced, the issue was resolved.After replacing the executive processor board, running test was performed normally for several days; however, the fault code 40 were confirmed to be recorded in the event log file after the running test was completed.Therefore the executive processor board was replaced again.Additionally the power management board, printer assembly, printer interface board and back plane board were replaced as well.After that, running test was performed again for three weeks without any further issues.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• 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: 18007627
• MDR Text Key: 326771496
• Report Number: 2249723-2023-04610
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 05/27/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.