MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problems Erratic or Intermittent Display (1182); Appropriate Term/Code Not Available (3191)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported that before use on a patient, the cs100 intra-aortic balloon pump (iabp) unit has a system failure and the display flickering.There was no patient involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields - b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10.Additional poc : (b)(4).A getinge field service engineer (fse) observed that system is showing system failure when it¿s starting auto fill procedure.Also observed that display is flickering, problem found with manifold drive assembly and display cable need to change.Replaced new manifold drive assembly and refixed the display cable then checked the system it is working fine.

Event Description

N/a.

• Brand Name: CS100 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: 17804681
• MDR Text Key: 324129887
• Report Number: 2249723-2023-04186
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.