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 Infusion or Flow Problem (2964)

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

Event Date 10/04/2021

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a low vacuum alarm.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the reported issue and determined that the drive assembly needs to be replaced.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had a low vacuum alarm.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The getinge field service engineer (fse) replaced the defective manifol drive of the device.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Manufacturer Narrative

Additional information: e1(event site postal code (b)(4)).

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. - 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: 12715217
• MDR Text Key: 281751937
• Report Number: 2249723-2021-02491
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 04/27/2022; 02/19/2024
• Supplement Dates FDA Received: 05/20/2022; 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1