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

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the reported issue.Upon inspecting the unit, the fse found that the motor controller board was defective and needed replacement.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted should this information be provided to us.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) displayed message error stating, electrical test fail # 50 (motor speed out of specification).It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that during a routine check performed by the customer's biomed, the cs300 intra-aortic balloon pump (iabp) had an "electrical test fail # 50 (motor speed out of specification)".There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: a1, a3(to be left blank), b4, b5, d5, e1(event site email), e2, e3, g3, g4, g7, h2, h6, h10, h11.Corrected field: h6(device codes).The getinge field service engineer (fse) that had evaluated the iabp unit reported that the motor controller board was cleaned with pcb cleaner and checked and run the iabp unit one hour and found it to be working properly.The fse then 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.

Manufacturer Narrative

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

Event Description

It was reported that during a routine check performed by the customer's biomed, the cs300 intra-aortic balloon pump (iabp) had an "electrical test fail # 50 (motor speed out of specification)".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: 11262097
• MDR Text Key: 230719284
• Report Number: 2249723-2021-00182
• 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,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1