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

Model Number N/A

Device Problem Failure to Sense (1559)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate. The stm troubleshot the iabp unit to determine which sensor was reported to not be working. During the performance and functional testing, the fiber optic (fo) sensor failed during the fo test. It was noted that no pulses were registered. Upon review of the log files, the stm observed a few ecg and pressure issues but no faults were recorded. The stm determined that the fo sensor assembly needed to be replaced. The stm returned the next day with the necessary parts and replaced the fo sensor assembly. Subsequently, the stm retested the iabp unit and noted that the fo test passed. Unrelated to the reported issue, the stm observed that the blood detect tubing was old and cracking. The stm replaced the blood detect tubing and connections then completed all safety, functionality, and calibration checks. All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.

Event Description

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

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10795848
• MDR Text Key: 215334628
• Report Number: 2249723-2020-01831
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse