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-UC-3013-45

Device Problem Gas/Air Leak (2946)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp) unit has air leakage.The customer reported that the iabp will alarm "iab loop air leakage" after about 10 minutes of normal operation and cannot work normally.There was no patient involved.

Manufacturer Narrative

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

Manufacturer Narrative

Due to character restrictions in block e1 telephone number : (b)(6).

Event Description

It was reported that during use, the cs100 intra-aortic balloon pump (iabp) unit has air leakage.The customer reported that the iabp will alarm "iab loop air leakage" after about 10 minutes of normal operation and cannot work normally.After the machine alarmed, the customer replaced the backup machine.There was no patient harm.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) states during on-site inspection, it was suspected that the driver valve group was damaged.After the fse replaced the drive valve group, the machine alarm was eliminated and passed the performance and safety index test specified by all factories.The equipment has been delivered to the customer and can be used clinically.

• 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: 18386549
• MDR Text Key: 331487116
• Report Number: 2249723-2023-05478
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2024

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-UC-3013-45
• Device Catalogue Number: 0998-UC-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: 01/26/2024; 03/10/2024
• Supplement Dates FDA Received: 01/31/2024; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.