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 Circuit Failure (1089)

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

Event Date 11/07/2023

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 fiber optic malfunction.There was no patient harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse tested cardiosave and examined fault logs, observed no critical fault to fiber optic circuit.Observed numerous fault 25, corrective action to reload software as per service manual.Reloaded b17 software.During pneumatic leak test membrane leak test failed during pim test, replaced safety disk and corrected failure.Unit passed all functional and safety tests per factory specifications, returned to customer.The maquet failure analysis and testing (fat) department received the safety disk associated with this complaint.This part was received with a unit failure message of membrane leak tests failed that was observed by the fse during the repair for the reported failure of fiber-optic malfunction which had no issue.Performed visual inspection of this part received and part looks be in condition.Installed the safety disk into the cardiosave test fixture and tested to the factory specifications per procedure and the cardiosave service manual.The failure analysis and testing department could not verify the failure message of membrane leak tests failed.Membrane diff.Pre.Leak test passed with result of 4 mmhg; the factory specification is +-6 mmhg.Safety disk passed testing.Retaining safety disk in the fat dept.As per procedure.

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: 18139871
• MDR Text Key: 328239741
• Report Number: 2249723-2023-04875
• 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
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1