MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-45

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) units iab loop is leaking.There was no patient harm reported.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse replaced the safety disk (0997-00-0985-15).The fse stated that the safety disk automatically tests the positive pressure leakage of 4mmhg, and the manual test of the x1 sensor and can obtain a positive pressure leakage of more than 10mmhg, where the maximum is 42mmhg.Also, the fse stated that the equipment alarm log cannot display the alarm.The fse performed all functional and safety checks to factory specifications.The unit was returned to the customer and cleared for clinical use.

Event Description

N/a.

Manufacturer Narrative

The following investigation was performed by a technician of the maquet national repair center (nrc) wayne, nj: the nrc received safety disk with the reported complaint of the safety disk failing the pressure test.The national repair center installed the safety disk into the cs 300 test fixture and tested the safety disk to factory specifications per the cs300 service manual.The nrc performed the safety disk leak test with passing results per factory specifications.K5 vacuum test 0 mmhg; k3 vacuum test 0 mmhg; pressure test -1 mmhg.Retaining the safety disk in the nrc per procedure number.

• Brand Name: CS300 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: 15236770
• MDR Text Key: 304922175
• Report Number: 2249723-2022-02093
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108575
• UDI-Public: 10607567108575
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063525
• 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,Followup
• Report Date: 03/05/2024

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: 0998-00-3023-45
• Device Catalogue Number: 0998-00-3023-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 04/15/2023; 03/05/2024
• Supplement Dates FDA Received: 04/24/2023; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose