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 Component Missing (2306)

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

Event Date 03/11/2024

Event Type  malfunction  

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) had no tightening system.The ready console arrived at the customer without clamping system or helium bottle.There was no patient involved.

Manufacturer Narrative

Updated data: b4, e1(initial reporter), e2, e3, g2, g3, g6, h2, h10.

Event Description

N/a.

Manufacturer Narrative

The field service engineer evaluated the unit and replaced the clamping system knob and tank valve.All functional and safety checks have been performed to meet factory specifications.

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: 18933381
• MDR Text Key: 338101366
• Report Number: 2249723-2024-01163
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: 10607567108308
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1