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 Problems Inability to Auto-Fill (1044); Failure of Device to Self-Test (2937)

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

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the cardiosave intra-aortic balloon pump (iabp) unit involved in this reported event.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during software upgrade the cardiosave intra-aortic balloon pump (iabp), after the installation steps were followed and the unit shuts down, the usb was unplugged and upon starting of the unit the device will stay on the startup screen and alarm.The unit cannot enter the normal mode and engineering mode.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The national repair center (nrc) received the pcba, video generator.A technician of the maquet national repair center (nrc) inspected the pcba, video generator per procedure and observed that the board was returned without the u43 microprocessor cooling fan that was unscrewed from the board.In addition to that, the board was not sent back in an anti-static bag.Inspection of the pcba, upper display monotor was completed per procedure with no visual damage observed.However the board was not returned in an anti-static bag.The nrc installed the boards into the cardiosave test fixture and tested the boards to factory specifications per procedure and the cardiosave service manual.The nrc verified the failure of the device staying on the start up screen and an alarm sounding.The software would not download.The video generator board was the cause of the failure.The video generator board failed testing.The upper display board passed testing.Retaining the boards in the national repair center per procedure.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

A getinge authorized dealer engineer resolved the issue by replacing the pcba, upper display monitor and pcba, video generator.The engineer performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: e1, h6 (medical device - problem code, component codes).

Event Description

N/a.

• 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: 12858270
• MDR Text Key: 283248007
• Report Number: 2249723-2021-02722
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.