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

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) unit has an electrical test failure #50.There was no patient involvement.

Manufacturer Narrative

Updated fields - b4,d1(brand name),d4(version or model #,catalog #),d9,e1(event site postal code - (b)(6),event site state- 10),g3,g6,h2,h3,h6(type of investigation,investigation findings,component code,investigation conclusions),h10.Getinge field service engineer (fse).No patient involved.Observed that system is showing electrical test failure #50.Checked the system properly problem found with motor controller board so that has to be replaced system is not working that has to be replaced dated 10/05/2024 replaced new motor controller board which customer has purchased.Then checked the system with demo balloon & trainer it is working fine and ready to use.

Event Description

N/a.

• 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: 18346261
• MDR Text Key: 330849623
• Report Number: 2249723-2023-05330
• Device Sequence Number: 1
• Product Code: DSP
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.