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 Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that during start-up, the cardiosave intra-aortic balloon pump (iabp) had an electrical test failure 13.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during start-up, the cardiosave intra-aortic balloon pump (iabp) had an electrical test failure 13.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and replaced the power management board and executive processor board to fix the issue.The safety disk and tidal volume disk were also replaced.The fse could not get the iabp to replicate the reported issue after that, 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 to the customer and cleared for clinical service.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1 (site country), e2, e3, g3, g6, h2, h6 (type of investigation), h10.

• 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: 11678404
• MDR Text Key: 246022405
• Report Number: 2249723-2021-00798
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/29/2021; 03/05/2024
• Supplement Dates FDA Received: 05/24/2021; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1