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 Failure to Sense (1559)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and determined that the main board and datasets required replacement.Repairs are ongoing and pending replacement parts.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the helium cylinder indicator for the cs300 intra-aortic balloon pump (iabp) was not working.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that before use, the helium cylinder indicator of the cs300 intra-aortic balloon pump (iabp) was not working.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: h6 (component codes).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and no helium bottle icon was showing on the display, the fse did the helium transducer calibration but the calibrated value was not storing on the main pcb.The fse determined that the main board and datasets required replacement.The fse replaced the main board to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.

• 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: 12706371
• MDR Text Key: 281846390
• Report Number: 2249723-2021-02474
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 04/13/2023
• Supplement Dates FDA Received: 11/22/2021; 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1