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

Model Number 0998-00-3023-64

Device Problem Failure to Sense (1559)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the unit and after checking the pump, the logs and having a conversation with the users about the issue, it appears that it was all a use problem.According to what the users claimed, they were surprised to see the pump stopped to perform the balloon fo calibration.Their first reaction began by touching "many keys", they finished with no augmentation (unit "not pumping") and the low diastolic pressure alarm.The users finally swapped to "manual" mode and the patient could be transferred with no injury.When the investigation to the user was completed, the fse complete a preventive maintenance (pm) on the machine.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.A supplemental report will be submitted when additional information is provided to us.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a fiber optic problems and the user had to move it to make it work.The patient was transferred to another hospital with no injury linked to the unit.The service engineer will check this iabp during the normal pm.

Manufacturer Narrative

Updated fields; b4, b6, b7, d4, d9, g3, g6, g7, h2, h6, h10, h11.Corrected fields: d1, g1.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 11939434
• MDR Text Key: 259720798
• Report Number: 2249723-2021-01180
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: 10607567108308
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SENSATION BALLOON
• Patient Sex: Prefer Not To Disclose