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

Model Number N/A

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.To fix the issue, the fse replaced the motor control board, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during a routine check, the cs100 intra-aortic balloon pump (iabp) had an electrical test error #50 during start up.The unit alarmed for the reported malfunction.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h4, h6 (type of investigation), h10.

Event Description

It was reported that during a routine check, the cs100 intra-aortic balloon pump (iabp) had an electrical test error #50 during start up.The unit alarmed for the reported malfunction.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
• MDR Report Key: 11645208
• MDR Text Key: 244896726
• Report Number: 2249723-2021-00754
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• 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
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/20/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/24/2021
• Patient Sequence Number: 1