MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Circuit Failure (1089); Appropriate Term/Code Not Available (3191)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had an error code #5 maintenance required.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10, h11.Corrected fields: b5, e2, h6 (medical device - problem code).A getinge field service engineer (fse) was dispatched to evaluate the unit and was able to replicate the reported malfunction.Once the unit powered down, the unit would lose the memory and display "battery maintenance required".The fse replaced the main board.The fse performed full functional and safety tests.The iabp was returned to the customer and cleared for clinical use.The following investigation was performed by the technician of the maquet failure analysis and testing dept.(b)(6).The nrc received keta pcb iabp main board with a reported failure of when unit was powered down the unit would lose memory and display battery maintenance required.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.After testing the unit , the failure analysis and testing dept.Was able to replicate the failure experienced by the customer.The board failed testing.Retaining the board in the failure analysis and testing dept.Per procedure.

Event Description

It was reported that after biomed replaced batteries as a preventative maintenance, the unit had an error code # 5, "battery maintenance required".It would save but as soon as the device was powered down it would lose the memory and display "battery maintenance required".There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 15520217
• MDR Text Key: 301183109
• Report Number: 2249723-2022-02423
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• 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: 10/30/2023

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: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1