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

Model Number N/A

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that when turning on the cs100intra-aortic balloon pump (iabp) and turning off the engine does not work.It is unknown under which circumstances this event occurred; however no adverse event was reported.

Event Description

It was reported that before use, when turning on the cs100 intra-aortic balloon pump (iabp), it turned off, the engine did not work.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, d4 (unique identifier (udi) #), g4, g7, h2, h6 (evaluation method codes), h10.

Manufacturer Narrative

Updated fields: a1, a3(to be left blank), b4, b5, e1(initial reporter & event site email), e2, e3, g3, g4, g7, h2, h3, h6, h10.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.In an attempt to fix the issue, the fse switched the solenoid driver board and mainboard; however, the iabp still did not turn on.In another attempt to fix the issue, the fse changed the power supply assembly and the iabp turned on.All functional and safety checks to meet factory specifications were performed.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 before use, when turning on the cs100 intra-aortic balloon pump (iabp), it turned off, the engine did not work.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: 10823089
• MDR Text Key: 219372871
• Report Number: 2249723-2020-01882
• Device Sequence Number: 1
• Product Code: DSP
• 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: 12/17/2020

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: 10/14/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/10/2020; 12/17/2020
• Supplement Dates FDA Received: 12/04/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1