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); Failure to Read Input Signal (1581)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) intermittently not printing.There was no patient involvement reported.

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) intermittently not printing.There was no patient injury or harm reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10, h11.Corrected fields: e1, e3, h6 (medical device - problem code).A getinge field service engineer (fse) evaluated the unit and confirmed that the printer intermittently did not print the numerical data after the ecg strip.The fse replaced the recorder, which resolved the issue.All calibration, functional and safety tests were performed.The unit was returned to the 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, with a reported unit failure of intermittent printing.The fat performed a visual inspection and found the part to be in good condition.The fat installed the part into cs300 test fixture and tested the part to factory specifications per the cs300 service manual.It was found that the part would not print properly.Fat was able to verify the reported issue.

• 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: 18148805
• MDR Text Key: 328284929
• Report Number: 2249723-2023-04902
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• 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: 11/08/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/24/2024; 03/13/2024
• Supplement Dates FDA Received: 01/29/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.