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 Battery Problem (2885)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that , the cs300 intra-aortic balloon pump (iabp) battery bar charging status not showing to indicate how many hours the unit will work on battery.

Manufacturer Narrative

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

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) battery bar charging status not showing to indicate how many hours the unit will work on battery.There was no patient involvement.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, e1 (initial reporter), h6 (clinical and impact code).Updated data: b4, e1 (email and phone#), g3, g6, h2, h10, h11.

Manufacturer Narrative

Updated fields: e1(event site address: (b)(6) ), h6(type of investigation, investigation findings, investigation conclusions), h10: it was reported that during routine check up the cs300 intra aortic balloon pump (iabp) had battery charging indicator malfunction / battery malfunction.A getinge field safety engineer (fse) was dispatched to evaluate the unit.Battery bar charging status not showing to indicate how many hours the unit will work on battery.Replaced the battery with new ones and the power management, but the issue remains.This raised a concern to the end user and made them remove the unit from service until further explanation is provided.The device is fully functional, but the charging battery status bar is not showing up.Still, nothing changed.The recommended action is to replace the power supply block.However, this raised customer concern on how they want to change the board and the device is fully functional.Complaint will be closed and in the event new information was to become available, this record will be reopened and updated.

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: 18564118
• MDR Text Key: 333484035
• Report Number: 2249723-2024-00301
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.