MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was unable to reproduce the reported issue.However, upon evaluating the unit, the fse determined that the power supply board was the cause of the reported issue.To fix the issue, the fse replaced the power supply board.The fse then performed 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 during a daily routine check, the cs100 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a daily routine check, the cs100 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a daily routine check, the cs100 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11068897
• MDR Text Key: 224598450
• Report Number: 2249723-2020-02178
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: 10607567107745
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1