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 Appropriate Term/Code Not Available (3191)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) units connector seems to be low in order to connect the fiber optic.

Manufacturer Narrative

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

Manufacturer Narrative

Updated sections: b4, e2, e3, g2, g3, g6, h2, h10, h11.Corrected sections: b5, b6, b7, d10, h6(health clinical and impact codes).

Event Description

It was reported prior to use on a patient, that the cardiosave intra-aortic balloon pump (iabp) units connector seems to be low in order to connect the fiber optic.There was no patient involved.

Manufacturer Narrative

Updated fields - b4, d9, e1(site country), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10, h11.Corrected fields - d5, e3, e2.Getinge field service engineer (fse) was confirmed the issue.Fiber optic connector issue was resolved by installing a new cable assembly fo sensor extension.Complete full calibration, replaced cbl, assy ,fo sensor extension(d012-00-1562) functional testing and safety check to factory specifications.Returned to the customer and cleared for clinical use.

Event Description

N/a.

Manufacturer Narrative

The previous aware date was incorrectly submitted as 05/02/2016.The correct awareness date is 03/08/2024.

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: 15631817
• MDR Text Key: 304001963
• Report Number: 2249723-2022-02712
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2024

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: 10/11/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 10/20/2022; 05/02/2016; 03/08/2024
• Supplement Dates FDA Received: 11/02/2022; 03/11/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1