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 No Display/Image (1183)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient transport, the cardiosave intra-aortic balloon pump (iabp) unit' screen went blank.There was no patient harm.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval?, return to manufacture date), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions, component code), h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) screen went blank during patient transport.There was patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Investigated the customer's complaint with screen went blank.Fse cannot reproduce the customer issue.Customer sent the photo of the display.With reviewing the logs there was fault code 137 and 139.This device has had the video generator pcb replaced 2 times with the past couple of years and a touchscreen.Replaced top level display assy and reloaded b.17 sw.Functional tested without any further issue or failures.Cardiosave iabp services completed.Safety, calibration, and functionality checks to factory specifications.Released to customer and cleared for use.The failure analysis and testing dept.Received part number 0997-00-1181 serial number (b)(6), with a reported unit failure of a blank screen and a fault code 137 and 139.The fat performed a visual inspection and found the connector for the display was cut off.Please see attachment.Not able to test the display due to the cord being cut.Fat is not able to confirm the fault.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

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: 18193144
• MDR Text Key: 328816180
• Report Number: 2249723-2023-04980
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• 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
• Report Date: 05/09/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.