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

Model Number 0998-00-3023-55

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse cleaned the pressure transducer and ran the iabp for more than two hours without an issue.The iabp was functioning properly.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had electrical test failure 52.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during routine check the cs300 intra-aortic balloon pump (iabp) had electrical test failure 52.There was no patient involvement.

Event Description

It was reported that during routine check the cs300 intra-aortic balloon pump (iabp) had electrical test failure 52.

Manufacturer Narrative

Updated data: b4,b6,b7,d10,e2,e3,g2,g3,g6,g7,h2,h10,h11.Corrected data: b5,d1(brand name),d5,h6(clinical & impact).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 11769971
• MDR Text Key: 249068709
• Report Number: 2249723-2021-00933
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/24/2023; 05/09/2023
• Supplement Dates FDA Received: 05/04/2023; 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1