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 Gas Output Problem (1266)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a rapid gas loss alarm.

Manufacturer Narrative

Additional contact information: contact person, email address, and phone number: (b)(6).Occupation: biomedical engineer.It was being reported that the cs300 intra aortic balloon pump (iabp) had an issue regarding the "rapid gas loss".A getinge field service engineer (fse) had tested the cs300 and observed in fault log that there was a rapid gas loss alarms along with "leak in iab circuit".Than the fse had performed all the leak tests and passed to specifications.It could of duplicate failure connections to balloon could have cause "rapid gas loss alarm" based on fault logs.Unit passed all functional and safety tests per factory specifications returned to the customer and cleared for the clinical use.The involvement of the patient is unknown.

• 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: 15919255
• MDR Text Key: 307905114
• Report Number: 2249723-2022-03107
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1