MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-UC-3023-53

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs300 intra-aortic balloon pump (iabp) the display had horizontal lines on the bottom as well as blurry spots.There was no patient involvement reported.

Manufacturer Narrative

The service territory manager (stm) evaluated the unit on a later date.The stm successfully completed a function check with testing catheter and trainer without issue upon initially testing unit.In order to solve the issue, the stm replaced display, display grid/casing, and display cable, and successfully obtained a clear display without issues.The coiled cord, when attempted out of the box, produced electrical test fails code 120.The existing coiled cord was left on unit, fully functional, which would have been replaced as a precaution.Preventative maintenance (pm) was completed successfully with measurements and calibration information separately.The unit was calibrated and passed all functional and safety tests per factory specifications.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: d1, d4.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: 18608751
• MDR Text Key: 334514255
• Report Number: 2249723-2024-00375
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: 10607567108704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-UC-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.