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 Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit displayed failure alarm error code #120.The rn on duty call for assistance for the alarm.The pump was emitting a very loud, screeching sound.She was advise to reboot the pump which did not resolve the issue, she was then advise to switch out the console immediately, but they did not have a backup.Although the account has two consoles the other one was in use.The patient was scheduled to be transferred to a higher level of care in the next few hours, so the rn was walk through the manual syringe inflation q5 minutes.There was no patient harm or injury reported.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10, h11 corrected fields: h6(problem code) a getinge field service engineer (fse) was able to duplicate the etf 120 isolated failure to keypad controller pcb.So, the fse replaced the part.The fse then performed calibration check, functional testing and safety check to factory specifications.Unit passes all functional checks and is ready for patient use.The maquet failure analysis and testing dept.(fat) received pcb, keypad controller with a reported unit failure of electrical test failure code 120.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed pcb, keypad controller into the cs300 test fixture and tested the board to factory specifications per the cs300 service manual.When the unit was turned on and the self test was completed, the fat did not observe code 120 on the display.The fat performed the keypad test and the board passed testing.The fat could not replicate the failure that the customer experienced.Retaining the part in the failure analysis and testing department per procedure.

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: 17445847
• MDR Text Key: 320255862
• Report Number: 2249723-2023-03486
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/03/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 97 KG