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 Circuit Failure (1089)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported the cs300 intra-aortic balloon pump (iabp) had a circuit failure while unit was being used for training.It is unknown if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

The event site name in is shortened due to field character limit.The full name is (b)(6).Testing of actual/suspected device: a getinge field service tech evaluated the unit for iabp circuit failure and to fix the issue turned the unit on to check for any start up failures.Everything was ok so then the fst put a test balloon on trainer and ran the unit and all worked as it should.The fst then ran the unit for approximately 30 minutes with no issues and could not duplicate the problem.The fst ran the unit through a complete calibration and electrical safety test and the unit was cleared for customer use.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields - b4, e1(site country), e2, e3g3, g6, h2, h4, h6(type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields - g2, d5.

• 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: 14522625
• MDR Text Key: 292819231
• Report Number: 2249723-2022-01255
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.