MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Failure to Zero (1683)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported during a routine check ,the cs100 intra-aortic balloon pump (iabp) zero pressure signal not executing by machine.There was no patient involvement reported.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse replaced the front end pcb after determining that it was defective.The zero function was working properly.The iabp was handed over to the customer in good, working condition.

• Brand Name: CS100 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: 18418664
• MDR Text Key: 331600522
• Report Number: 2249723-2023-05555
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1