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

Model Number 0998-00-3023-67

Device Problems Gas Output Problem (1266); Appropriate Term/Code Not Available (3191)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the cs300 intra-aortic balloon pump (iabp) unit involved in this reported event.The getinge field service engineer (fse) advised that the customer was contacted and performed the repair to the unit involved in this reported event due to the problem being connected to the helium tank / gasket.Based on the information available at this time, the reported issue was resolved by replacing the helium tank.The iabp was then returned to clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported by the customer that during use the cardiosave intra- aortic balloon pump (iabp) unit began to sound a deafening whistle that was found to be coming from the helium cylinder.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Additional information: e1(event site postal code: (b)(6)).

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, UNKNOWN
• 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: 13013236
• MDR Text Key: 284019974
• Report Number: 2249723-2021-02880
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1