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 Connection Problem (2900)

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

Event Date 07/25/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse arrived on site and checked the logs, he was unable to see any issue with the pressures.The fse connected his patient simulator and was able to zero the pressure and measure the pressure within tolerance.In addition, the customer did not have the pressure cable that was used during this issue and the fse was unable to verify if the user's cable has a malfunction.Subsequently, the fse perform all the test and calibrations.Unit passed all calibration, functional and safety tests performed as per manufacture specifications.The iabp was returned to the customer and cleared for clinical use.A supplemental report will be submitted when the investigation is completed.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a sensor failure with the pressure cable and the unit stopped reading the pressure while providing therapy on a patient.The iabp was switched and the pressure cable functioned correctly.No patient harm, serious injury or adverse event was reported.

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: 12332140
• MDR Text Key: 266918706
• Report Number: 2249723-2021-01840
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION 34CC.; SENSATION 34CC.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG