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

Model Number N/A

Device Problem Failure to Zero (1683)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp and was unable to reproduce the reported issue.In attempts to verify the reported issue, the fse tested the unit with a system trainer and the unit was able to zero, and therefore, no issue was found.The fse then performed all necessary checks and released the unit to the customer in good working condition.

Event Description

It was reported that prior to utilizing the cs300 intra-aortic balloon pump (iabp) on a patient, the unit was unable to zero.However, there was no patient involvement, and no adverse event reported.

Event Description

It was reported that prior to utilizing the cs300 intra-aortic balloon pump (iabp) on a patient, the unit was unable to zero.However, there was no patient involvement, and no adverse event reported.

Event Description

It was reported that prior to utilizing the cs300 intra-aortic balloon pump (iabp) on a patient, the unit was unable to zero.However, there was no patient involvement, and 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
• MDR Report Key: 10994255
• MDR Text Key: 225339027
• Report Number: 2249723-2020-02127
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1