MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse inspected the unit and found the additional alarms 61 iabp shutdown, system failure.And high drive pressure.The fse replaced the front end board and pressure transducer to test the machine for 24 hours and observe if the issues occurred again.A supplemental report will be submitted upon receipt of additional information.The full name of the initial reporter is (b)(6).The full name of the event site address was shortened due to field character limit; the full name is (b)(6) hospital.

Event Description

It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) displayed electrical test fails code # 52.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

The getinge field service engineer (fse) that evaluated the unit, additionally replaced the pressure transducer.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.A supplemental report will be submitted upon completion od our evaluation.

Event Description

N/a.

Manufacturer Narrative

Event site postal code: (b)(6).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 13254376
• MDR Text Key: 287282652
• Report Number: 2249723-2022-00066
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 03/05/2024

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: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 05/13/2022; 03/01/2024
• Supplement Dates FDA Received: 06/06/2022; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1