MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Premature Discharge of Battery (1057); Break (1069)

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

Event Date 12/07/2023

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) unit has a broken iv pole holder.It was also discovered that the device failed the battery run test at 71 minutes of the 135 minute test.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

The getinge service territory manager (stm) that discovered the issue, replaced the pole mount and batteries to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.Device was returned to customer.

Manufacturer Narrative

**udi related data quality updates only** providing updated device identification information in alignment with gudid.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18362791
• MDR Text Key: 330941374
• Report Number: 2249723-2023-05367
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: (01)10607567107882(21)SI190778D1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• 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: 09/21/2024

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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/26/2024; 09/21/2024
• Supplement Dates FDA Received: 01/26/2024; 10/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1