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

Model Number 0998-00-3023-53

Device Problem No Display/Image (1183)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and cleaned the coiled cable contacts. The display connections were also checked but the fse was unable to duplicate the customer's reported issue. No problems were observed. Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the screen for the cs300 intra- aortic balloon pump (iabp) went blank. It was later reported that the display would go blank but came back on and the iabp unit did not stop assisting. The iabp unit was swapped with another iabp unit but the patient passed away. The customer has not attributed the patient's death to the reported issue. The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00486. Screen stude blank while on patient. Screen stude blank while on patient. Patient passed due to switching equip over. Po: (b)(4) all information given by contact person, (b)(6). (b)(4). Cs300,english,110v,domestic. (b)(4).

• Brand Name: CS300
• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12276549
• MDR Text Key: 265065391
• Report Number: 2249723-2021-01717
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/04/2021 Patient Sequence Number: 1