MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had printer issues.There was no patient harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11 corrected data:b5,e3.

Event Description

It was reported that during use, the cs300 intra-aortic balloon pump (iabp) unit had printer issues.There was no patient harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the unit and confirmed that the printer failed printing the second half of the recorder test.It did not print the numerical data after the square wave portion of the strip.The motor was working but the paper was not being dispensed.The fse replaced recorder which resolved the issue.The unit passed all calibration, functional and safety tests.The unit was returned to customer, and cleared for clinical use.The following investigation was performed by technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The failure analysis and testing dept.Received recorder iabp with a reported unit failure of the recorder printing intermittently.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed recorder iabp into the cs300 test fixture and tested the recorder to factory specifications per the cs300 service manual.The fat could not replicate the failure of an intermittent recorder, after running a complete roll of recorder paper in the continuous mode.The recorder passed testing.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 18312378
• MDR Text Key: 330354277
• Report Number: 2249723-2023-05249
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 03/13/2024
• Supplement Dates FDA Received: 12/21/2023; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1