MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, CHINESE,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problem Gas/Air Leak (2946)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during during the department's weekly routine start-up inspection, the cs100 intra-aortic balloon pump (iabp) unit has air leakage in the loop and could not work after the equipment was turned on, there was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusion), h10, h11 corrected fields: d4(version or model #, catalog #, unique identifier (udi) #) additional contact details: event site postal code- (b)(6) it was reported that cs100 intra-aortic balloon pump (iabp) with loop leakage.Getinge field service engineer (fse) after on-site inspection, it was determined that the equipment can be repaired by replacing the 5000-hour maintenance kit.The device was not used for treatment when the fault occurred.Since the customer has not confirmed the repair plan and price, the repair has not been carried out yet and the repair of the equipment has not been completed.If there is any change, fse will update it in time.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.No patient involvement.H3 other text : customer has not confirmed the repair plan and price.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, CHINESE,NON-UTS,INTL
• 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: 18384565
• MDR Text Key: 331249461
• Report Number: 2249723-2023-05475
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 08/26/2015
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1