MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problems Leak/Splash (1354); Failure to Sense (1559); Gas/Air Leak (2946)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) machine is showing ,multiple error such as no trigger/leak in iab/rapid gas loss.There was no patient harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse replaced the front end board and drive manifold assembly.The fse then performed all calibration and function test, which the unit passed.The unit was then working fine and was able to be put for regular use.

• 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: 18518212
• MDR Text Key: 332929683
• Report Number: 2249723-2024-00177
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1