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 Problem Leak/Splash (1354)

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

Event Date 04/07/2024

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 use, the cs100 intra-aortic balloon pump (iabp) has a loop leakage.The unit was immediately replaced with a spare device.There was no personal injury reported.

Manufacturer Narrative

Additional information: ( event site state: (b)(6).A getinge field service engineer(fse) suggested to repair the device.Repairs are not yet completed.No further information available.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer(fse) went to the customer site to perform the factory-specified tests and confirmed that the machine loop leaked due to the failure of the safety disk and maintenance kit.Fse replaced the safety disk and maintenance kit and perform the factory-specified tests.All of them passed and met the clinical use requirements and were delivered to the customer for use.

Event Description

N/a.

• 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.; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 19118316
• MDR Text Key: 340927887
• Report Number: 2249723-2024-01564
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2024

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: 04/07/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 07/08/2024; 08/23/2024
• Supplement Dates FDA Received: 07/08/2024; 08/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 55 YR
• Patient Sex: Male