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 Failure to Sense (1559)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had a problem with its fiber optic port.

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had a problem with its fiber optic port.There was no patient incident reported.

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5,e3,h6 (clinical & impact).

Manufacturer Narrative

Updated fields: b4, d9, e1 (site country), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the cardiosave intra-aortic balloon pump (iabp) unit and found that the plastic connector that the fiber plugs into was cracked and broken.It still tested ok but the connection was not very stable.To fix the issue, the fse replaced the cbl assy,fo sensor extension (0012-00-1562).The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

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: 15324609
• MDR Text Key: 302395650
• Report Number: 2249723-2022-02221
• 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,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1