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 Battery Problem (2885)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that the the cs300 intra-aortic balloon pump (iabp) had an error code 5 battery issue.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11 corrected fields: d10, e1 (event site email), h3, h6 (type of investigation, component codes) testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate.The fse turned on the iabp unit and received a maintenance code #5 message on the main screen.The fse reviewed the iabp log files and observed many error codes as well as some unknown error codes.The fse calibrated the helium transducer and replaced the datasettes.Subsequently, the fse performed a system check and calibration verification per the service manual, then ran the iabp unit on a trainer.The iabp unit passed all testing and was cleared for use and returned to the customer.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Event Description

N/a.

• 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: 12866481
• MDR Text Key: 284447783
• Report Number: 2249723-2021-02736
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1