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 05/08/2023

Event Type  malfunction  

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) found to have an out of range voltage on its solenoid driver board.Solenoid driver board replaced and the issue resolved.There was no patient involvement reported.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Additional point of contact: contact person name: (b)(6).A getinge field service engineer (fse) stated unit found to have an out-of-range voltage on its solenoid driver board during pm by getinge fse (b)(6) on 5/8/2023.Unit maintained by getinge fse (b)(6).Last service was a pm 12/22/2022 by getinge fst jackson daniel.No logs available, as they had been cleared by the point in the pm where the issue was found.Solenoid driver board replaced.Issue resolved.Unit passed all tests and calibrations to manufacturer standard and was released for clinical use.There was no patient involvement.The defective components were received for further investigation.The failure analysis and testing dept.Received part with a reported unit failure of the board's voltage being out of range.The fat performed a visual inspection and found the part to be in good condition.The fat installed the board into cs300 test fixture and tested the part to factory specifications per procedure and the cs300 service manual.During testing it was found that the voltage was out of range and not able to be adjusted.Fat was able to verify the reported issue.This board is obsolete and no longer able to be sent to the supplier for failure analysis.Retained the part in the failure analysis and testing department per procedure number (b)(6) rev.Ap.The non-conformances with the returned components were identified.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 16952591
• MDR Text Key: 315456913
• Report Number: 2249723-2023-02404
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 05/08/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1