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 07/20/2023

Event Type  malfunction  

Event Description

It was reported during an inspection the cs300 intra-aortic balloon pump (iabp) unit found to have out of range voltage readings on its solenoid driver board.There was no patient involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: e1(event site telephone(b)(6).It was reported that the during inspection for the non-triggering issue getinge field service engineer (fse) discovered the cs300 intra-aortic balloon pump (iabp) had solenoid driver board issue.The voltages on the solenoid driver board were out of range.Fse replaced solenoid driver board.No patient involvement.Unit passes all tests and calibrations to manufacturer standard and is released for clinical use.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing dept.Received part number 0670-00-0639 r with a reported unit failure of the voltages being below acceptable range for the board tests.The fat performed a visual inspection and found the part to be in good condition.The fat installed the part into cs300 test fixture serial number (b)(6) and tested the part to factory specifications per procedure number (b)(4) and the cs300 service manual part number 0070-00-0689 rev w.The voltages on the solenoid driver board were out of range.Fat was able to verify the reported issue.Due to this part being obsolete, fat cannot send it to supplier for failure analysis.Retaining the part in the failure analysis and testing department per procedure number (b)(4).The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

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: 17417366
• MDR Text Key: 320129311
• Report Number: 2249723-2023-03421
• 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,Followup
• Report Date: 05/09/2024

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: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 04/25/2024; 05/09/2024
• Supplement Dates FDA Received: 04/26/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Sex: Prefer Not To Disclose