MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and resolved the artifact found on bp signal by replacing the front-end board.In regard to the unrelated reported issue, the fse replaced the top display assembly.Moreover, the fse replaced the primary 9v battery alkaline, safety disk, tidal volume disk, and scroll compressor, pursuant to manufacturer specifications.Notably, the scroll compressor was due for replacement, >5000 hours of operation.The fse then completed a pm, all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter named is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was found to have an artifact on the bp signal, without an external connection.In other words, the unit erroneously presented as though there was an external blood pressure signal.Additionally and unrelated, the iabp unit vertical lines through the image of the upper top display.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was found to have an artifact on the bp signal, without an external connection.In other words, the unit erroneously presented as though there was an external blood pressure signal.Additionally and unrelated, the iabp unit vertical lines through the image of the upper top display.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11379538
• MDR Text Key: 233545931
• Report Number: 2249723-2021-00408
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1