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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the unit and discovered that the safety disc was loose and not screwed in.The stm properly secured the safety disc and performed device checkout.It was conformed that there were no error codes listed in the log.The iabp was then functional tested without any further failures with all safety, calibration, and functionality checks to factory specifications.The iabp was released to customer and cleared for clinical use.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) failed its vacuum test.There was no patient involvement and no adverse event was reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) failed its vacuum test.There was no patient involvement and no adverse event was 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: 10510148
• MDR Text Key: 206515644
• Report Number: 2249723-2020-01451
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1