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

Model Number N/A

Device Problems Erratic or Intermittent Display (1182); Appropriate Term/Code Not Available (3191); Noise, Audible (3273); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and monitored the screen for approximately 30 minutes, at which time was able to verify the fluttering screen.The fse determined that the "fluttering screen" was the source of the reported noise emitting from the iabp unit.To fix the issue, the fse installed a new coiled cable.The fse then performed a preventative maintenance (pm) service, full calibration, and all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) made a lot of noise while the unit while running.It was further reported that the screen was fluttering while pumping which was the source of the noise reported.It is unknown the circumstances in which the even occurred, however there was no patient harm or injury and no adverse event reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) made a lot of noise while the unit while running.It was further reported that the screen was fluttering while pumping which was the source of the noise reported.It is unknown the circumstances in which the even occurred, however there was no patient harm or injury 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: 11055656
• MDR Text Key: 225339111
• Report Number: 2249723-2020-02169
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1