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

Device Problem No Display/Image (1183)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during routine checkt, the cs300 intra-aortic balloon pump (iabp) units display is not visible.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d1, d9, g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, investigation conclusion, component code), h10, h11.It was reported that during routine check the cs300 intra-aortic balloon pump (iabp) display not visible.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He checked the machine and found problem with video receiver board and display to video receiver cable.Needs replacement of both the partsunder cmc.Checked the machine and replaced the video receiver board alone,checked functionality of the machine found ok.Handed over the machine in working condition.

• Brand Name: CS300
• 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: 18133276
• MDR Text Key: 328132679
• Report Number: 2249723-2023-04852
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.