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

Model Number 0998-00-0800-52

Device Problem No Display/Image (1183)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) units screen had no signal.No image showed up during startup.There was no patient harm reported.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, component code, investigation conclusion), h10.A getinge field service engineer (fse) evaluated the unit and resolved the issue by replacing the pcba, video generator and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h10, h11.Corrected fields: h6 ( type of investigation).The defective components were received for further investigation.The failure analysis and testing department received the pcba, video generator with a reported unit failure message of screen no signal.Performed visual inspection of this part received and found saline on board.Due to saline on board, the fat dept cannot investigate video gen.Board with test fixture.This was probably cause of no signal on screen.Retained the board in the fat dept.As per procedure.Due to saline on board this board is not going back to supplier for further investigation.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 17906367
• MDR Text Key: 326253074
• Report Number: 2249723-2023-04392
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: MC
• 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,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.