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 Component Incompatible (1108); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.During investigation, the fse reported that boot test machine alarm, electrical test fail#50.The final test was that the motor control board was damaged.Repair was not completed.Parts are been ordered.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that during routine inspection, the cs300 intra-aortic balloon pump (iabp) has an electrical test # 50 failure.There was no patient involvement, and there was no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) replaced the pcb display controller.A supplemental report will be submitted if additional information is provided.

Manufacturer Narrative

Updated fields: b4, d9, g2, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: d1, d5, e2, h6, (medical device - problem code), h10.A distributor investigated the issue.The distributor turned on and tested the unit and observed the electrical test # 50 failure.It was then stated the issue was caused by a damaged motor control board.So, in order to solve the issue, the pcb display controller was replaced.The unit passed all functional and safety checks to factory specifications.The unit was then returned to the customer and cleared for clinical use.

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: 12266409
• MDR Text Key: 264708440
• Report Number: 2249723-2021-01681
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1