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 Problem Circuit Failure (1089)

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

Event Date 02/21/2023

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 cs300 intra-aortic balloon pump (iabp) unit had a solenoid driver board issue.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10.The fse that encountered the issue evaluated the unit and found solenoid driver board was out of the correct voltage range.There were no logs available as they had been cleared before this issue was discovered.The fse attempted to boost the voltage using board switches.To resolve the issue the fse replaced the solenoid driver board (0670-00-0639).Full pm, safety, calibration, and functionality checks passed factory specifications.Returned to clinical service upon completion.The maquet failure analysis and testing dept.(fat) received part number 0670-00-0639 pcb,solenoid driver with a reported unit failure of solenoid driver board has low voltage readings.The failure analysis and testing dept.Installed part number 0670-00-0639 pcb,solenoid driver into the cs 300 test fixture and tested the board to factory specifications per the cs300 service manual.The fat was able to replicate the failure of low voltage readings when the calibration procedure for the board was performed.The board failed testing.Part no longer able to be tested by the supplier.Investigation is complete.Retaining the part in the failure analysis and testing department per procedure.

Event Description

N/a.

• 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: 16469275
• MDR Text Key: 310529400
• Report Number: 2249723-2023-01355
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.