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 Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had an electrical test failure 58.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to confirm the reported electrical test failure 58.The fse replaced the solenoid driver board as part of a field action, and performed a full pm check, unit has passed all test and calibrations and is now ready for clinical use.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, e1(site country), g3, g6, h2, h4, h6(type of investigation, investigation findings, investigation conclusions), h10, h11 corrected fields: h6(health effect ¿ clinical code).

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: 13120160
• MDR Text Key: 287139026
• Report Number: 2249723-2021-03007
• 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: 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: 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?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/21/2022; 03/02/2024
• Supplement Dates FDA Received: 03/23/2022; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1