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 Device Output (1435)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) units printer is not printing.

Manufacturer Narrative

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

Event Description

It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) units printer is not printing.There was no patient involvement.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and upon arrival the fse tested the printer, and the printer operation was working.The fse could not duplicate a printer error.Upon further inspection, the fse found fault code 42 multiple times.The fse restarted the system as manual suggested, and printer was operating in accordance with manufacture specifications.During testing of iabp, the iabp failed the drive manifold test.The fse replaced the drive manifold, and iabp passed the drive manifold test.The fse performed a pm, full calibration, and tested the unit.The product passed all functional/safety testing.Returned the unit to the customer.The failure analysis and testing department received a drive manifold p/n 0104-00-0031, s/n (b)(6) , with a reported of the ¿unit failed the drive manifold test¿.Performed visual inspection of drive manifold per the cardiosave service manual and found no visual damage and the part looks to be in a good condition.Installed the drive manifold into cardiosave test fixture.Performed and tested in accordance with the cardiosave service manual.The tests (40 minutes) did trigger the reported problem of the ¿unit failed the drive manifold test¿.The failure analysis and testing department was able to verify the failure experienced by the customer.Retaining the drive manifold in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿impossible to define¿ due to the department not having the capabilities to troubleshoot this part internally further in an attempt to determine the root cause.

• 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: 17692241
• MDR Text Key: 322756357
• Report Number: 2249723-2023-03946
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1