MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) returned and performed the "software retrofit field corrective action". As per instruction the fse installed new datasets. The intra-aortic balloon pump (iabp) passed all calibration, functional, and safety tests performed. The iabp was then returned to the customer and cleared for clinical use.

Event Description

It was reported that during service test performed by a company representative on the cs300 intra-aortic balloon pump (iabp) the field service engineer (fse) made an attempt to complete software field service action and after installing the software he performed service diagnostics and the autofill test failed. There was no patient involvement or adverse event reported.

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. A getinge field service engineer (fse) attempted to complete software field service action, and after installing software he performed a service diagnostics and the auto-fill test failed. The fse tried another set of datasets, but the problem persisted. He then installed old b03i b03d and the problem was resolved. The fse reassembled the iabp to its initial state. Fse will return at later date to complete software fsa. Then performed functional and safety checks to meet factory specifications. The iabp was released to the customer and cleared for clinical service. The initial reporter named in report is a getinge employee who has different contact details from that of the event site. Details: (b)(6).

Event Description

It was reported that during service test performed by a company representative on the cs300 intra-aortic balloon pump (iabp) the field service engineer (fse) made an attempt to complete software field service action and after installing the software he performed service diagnostics and the autofill test failed. There was no patient involvement or adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7187348
• MDR Text Key: 108227063
• Report Number: 2249723-2018-00058
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/12/2018
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse