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 Premature Discharge of Battery (1057)

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

Event Date 07/07/2023

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 failed battery run test.There was no patient involvement reported.

Manufacturer Narrative

Additional information: contact person name: (b)(6); phone: (b)(6).The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) replaced the battery to fix the issue and performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The pm was completed and the iabp was then released and cleared for clinical service.The defective components was sent to getinge's failure analysis and testing (fat) for further investigation.The fat performed a visual inspection and found the part to be in good condition.The fat installed the parts into cs300 test fixture and tested the part to factory specifications per procedure and the cs300 service manual.The battery runtime test failed at 47 minutes.Fat was able to verify the reported issue.Parts was retained in the failure analysis and testing department.The non-conformances with the returned components were confirmed.

• 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: 17343382
• MDR Text Key: 319254677
• Report Number: 2249723-2023-03226
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• 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
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1