MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Low Audible Alarm (1016)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) it doesn't work, it can't be heard.

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) unit has a doppler related malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) it doesn't work, it cant be heard.

• Brand Name: CS300 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: 16702526
• MDR Text Key: 313021772
• Report Number: 2249723-2023-01840
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.