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 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) found the pcb power exc.Board replacement due.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, component codes, investigation conclusion), h10.The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) reporated that the cardiosave intra-aortic balloon pump (iabp) found unit due for pcb executive processor board replacement.Fse replaced the d670-00-0770 pcba, exec processor as a precaution.Fse then performed complete pm, performed functional and safety checks and cleared the device for clinical use.The defective components were received for further investigation.The failure analysis and testing department received the defective exec.Processor board.This part was received with a reported unit failure message of display failing.Performed visual inspection of this part received and part looks to be in good condition.Installed the exec.Processor board into the cardiosave test fixture and tested to the factory specifications per pn 0002-07-d016 revision d and the cardiosave service manual.The failure analysis and testing department could not verify the failure of display failing.The exec.Processor board passed testing.Exec.Processor board was retained in the fat dept.As per procedure 0002-07-d008 rev al.The non-conformances with the returned components were not confirmed.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h10, h11.Corrected fields: h6- type of investigation.The exec.Processor board was sent for supplier evaluation.The supplier returned the exec.Processor board to the failure analysis and testing (fat).The supplier stated that pcba do not have mac address label on it so analysis cannot be performed.Retained this board in the fat dept.Per procedure.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

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: 16303625
• MDR Text Key: 309063220
• Report Number: 2249723-2023-00977
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/13/2024; Not provided
• Supplement Dates FDA Received: 03/20/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.