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 Problem No Device Output (1435)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) has intermittent issues w/ the printer.

Manufacturer Narrative

Updated data: a2,a3,a4,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) has intermittent issues w/ the printer.Icu rn, called for assistance with a printer issue that troubleshooting did not resolve.The staff/md opted to keep this pump in service and chart numbers manually.There was no patient harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the unit and replaced the recorder interface board.The fse then performed a pm, will full calibration, and all functional and safety checks per factory specifications.The unit passed all tests performed and was returned to the customer.The maquet failure analysis and testing dept.Received pcb recorder interface with a reported unit failure of an intermittent printer.The failure analysis and testing dept.Performed a visual inspection and observed white residue on pcb recorder interface.Based on past experience, this residue is consistent with saline.Due to the saline on the board , the fat cannot investigate this complaint any further.Retaining the board in the fat per procedure.

• 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: 17930876
• MDR Text Key: 325611318
• Report Number: 2249723-2023-04442
• 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: 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: 03/27/2024

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: 10/05/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 03/27/2024
• Supplement Dates FDA Received: 10/19/2023; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 69 KG