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 Electrical /Electronic Property Problem (1198)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the main board.The unit passed all the functional and safety checks to the factory specifications.The iabp unit has been returned to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) displayed the electrical test failure code #04.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) displayed the electrical test failure code #04.There was no patient involvement.

Event Description

N/a.

• 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: 14042037
• MDR Text Key: 288783979
• Report Number: 2249723-2022-00756
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

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: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 06/06/2023; 07/18/2023
• Supplement Dates FDA Received: 06/15/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKOWN