MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-64

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) screen does not respond to switching on, black, no voltage indicator light while they can clearly hear the fan running downstairs.

Manufacturer Narrative

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

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5.

Event Description

It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) screen does not respond to switching on, black, no voltage indicator light while they can clearly hear the fan running downstairs.

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the unit for the reported malfunction.A supplemental report will be submitted if additional information is provided.H3 other text: not returned to manufacturer.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
• 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: 17965654
• MDR Text Key: 326048778
• Report Number: 2249723-2023-04521
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 02/15/2024
• Supplement Dates FDA Received: 10/25/2023; 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.