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

Model Number 0998-UC-3023-65

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during daily inspection, the cs300 intra-aortic balloon pump (iabp) unit screen display failed.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Due to character restrictions in block e1 event site name : (b)(6).Due to character restrictions in block e1 city : (b)(6).

Event Description

N/a.

Manufacturer Narrative

The getinge field service engineer (fse) replaced the video receiver board and display cable.Operational inspection was performed based on inspection records.The unit is in good condition.

Event Description

It was reported that during daily inspection performed by getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) unit screen display failed.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,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: 18357080
• MDR Text Key: 330894221
• Report Number: 2249723-2023-05346
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: 10607567108803
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-UC-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1