MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-64

Device Problems Failure to Sense (1559); Appropriate Term/Code Not Available (3191)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and found nothing in the logs but did find a fiber optic connector cut off from the orange cable. Upon reinsertion, the fse noticed a resistance a little bit more than usual but finally connected it correctly. The fse determined that the probable cause of the incident was incomplete insertion related to the unusual "hardness" found of the connector. After 2 hours of testing, the fse completed a pm with full calibration, functional and safety checks to meet factory specifications. Unit passed all calibration, functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) had a fiber optic fault. The unit was swapped out with another to continue therapy. No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
• 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: 12697871
• MDR Text Key: 278382734
• Report Number: 2249723-2021-02457
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: 10607567108308
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/1999
• Is the Device Single Use?: No
• Type of Device Usage: Reuse