MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE D PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-33

Device Problem Gas/Air Leak (2946)

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

Event Date 03/10/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) had a gas loss in iabp circuit error.The user switched patient on another working unit.There was no harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and it was requested to the user to switch patient on another working unit so that suspected unit can be made available for testing purpose.The same balloon catheter which is connected to the patient is now switched to another working unit.That system started showing the same error message on it too.Then the balloon catheter is been replaced with the new one, no error message observed then after.Checked performance of the reported unit on iabp trainer & demo balloon catheter for more than 2 hrs., no issue observed.Performed all manifold test, passed ok.System working satisfactorily both on ac mains as well as on battery.Hence, problem found with the balloon catheter, which is already been replaced.The fse handed over equipment to customer in good working condition.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE D PLUG
• 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: 18932035
• MDR Text Key: 338016530
• Report Number: 2249723-2024-01160
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: 10607567109008
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K112372
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.