MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Power Problem (3010)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/24/2023

Event Type  Death  

Manufacturer Narrative

In addition original event date was specified as (b)(6) 2023 but aware date is still 1/24/2023.A supplemental report will be upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was not switching on, power supply and motor controller pcb are found defective due to moisture found.Patient involved.Patient had post mi vsr surgery where patient condition was already critical, even in pre op iabp was connected to patient, later on the 19th they have did surgery where iabp was on standby, after surgery they shifted patient to icu where after some time patient was passed away.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse visited the site and found that the unit was not working, as well as, a short circuit in the unit.The fse checked and found the power supply and motor control board to be defective, due to liquid.It was also stated that the battery pack was also in need of replacement.The fse then stated that a quotation was then going to be submitted to the customer.It was later informed by the fse that the po still has not been received from the customer.This complaint will be closed, if further information is received in regards to the repair of the unit, the complaint will be opened and updated accordingly.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 16302805
• MDR Text Key: 308822479
• Report Number: 2249723-2023-00962
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DATASCOPE BALLOON, SIZE 40CC
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG