MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character restrictions in block e1 telephone number : (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during power on test, the cs100 intra-aortic balloon pump (iabp had not been used for a long time.During the power-on test, they found that the display could not light up, the device could not be powered on, and only the sound of the fan could be heard.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), e1(event site address), g3, g6, h2, h3, h4, h6(problem code, investigation type, investigation findings, component codes & investigation conclusions), h10 a getinge field service engineer (fse) evaluated the unit.The computer could not be turned on, the fan was spinning, and the timer had no display.It was determined that the power supply was faulty and spare parts were available.Fse returned and replaced the power management board and a comprehensive performance test was conducted on the device in accordance with the maintenance manual guidance documents.All functions were normal, and the device was handed over to the customer and can be used clinically.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 18687059
• MDR Text Key: 335308627
• Report Number: 2249723-2024-00550
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1