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 Electrical /Electronic Property Problem (1198)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had an unresponsive screen.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

Type of investigation not yet determined.A supplemental report will be submitted upon receipt of additional information.The initial reporter¿s name in is shortened due to field character limit.The full name is (b)(6).

Manufacturer Narrative

A getinge fse assisted the biomed who reached out about cardiosave serial number (b)(6) having an unresponsive screen.As such, repairs will be completed in-house without a getinge service call.No logs available.The biomed ordered touchscreens to repair unit.Touchscreen is completely unresponsive and disallows any progress from the service mode start up screen to any other service mode sub menus.Perfusion discovered subject issue as part of daily checks, and reported the repair to biomed.No further information is available complaint will be closed and in the event new information was to become available, this record will be reopened and updated.No service order available and there is no relevant repair information available.H3 other text : repairs will be completed in-house.

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: 13206995
• MDR Text Key: 288213741
• Report Number: 2249723-2022-00035
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/24/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 02/24/2024
• Supplement Dates FDA Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1