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

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge service territory manager (stm) that encountered the issue, replaced the oob datasette with another new datasette, and 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.The suspected faulty oob datasette was sent to getinge's national repair center (nrc) for evaluation.A senior repair technician inspected the datasette and no visual damage was observed.The technician then installed the datasette into cs100 test fixture and it tested to factory specifications per cs100 service manual and it failed testing.The technician verified the reported failure of no power up or display.The datasette is being sent to the supplier for failure analysis as per procedure.(b)(6).

Event Description

It was reported that during a field service corrective action (fsca) recall related to a software update that was performed by a getinge service territory manager (stm), the new datasette for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.This is an out of box (oob) failure.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7,h2, h10.The supplier verified the reported failure.They stated u1 was defective and unable to reprogram.The supplier scrapped dss datasette p/n 0670-00-1185 s/n (b)(6).

Event Description

It was reported that during a field service corrective action (fsca) recall related to a software update that was performed by a getinge service territory manager (stm), the new datasette for the cs100 intra-aortic balloon pump (iabp) failed to work when installed.This is an out of box (oob) failure.There was no patient involvement, and no adverse event was 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: 9125172
• MDR Text Key: 188688161
• Report Number: 2249723-2019-01549
• 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
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1