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 Inability to Auto-Fill (1044); Leak/Splash (1354)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

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) had a circuit leakage alarm and an automatic inflation failure occurred after restarting.The equipment was deactivated and no injuries were caused.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, e1, g3, g6, h2, h3, h4, h6, h10, h11.Due to character restriction block e1 event site telephone is (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the issue was confirmed through the unit logs.The fse replaced the safety disk, and the unit passed all functional and safety tests.

• 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: 18928611
• MDR Text Key: 337955575
• Report Number: 2249723-2024-01156
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.