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

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cs100 intra-aortic balloon pump (iabp) had electrical failure 50 reading on screen.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue replaced the main board due to the broken connector, and completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter named in block e1 reported in the initial emdr 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 preventive maintenance (pm) performed by a getinge service territory manager (stm), the cs100 intra-aortic balloon pump (iabp) had electrical failure 50 reading on screen.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) had electrical failure 50 reading on screen.There was no patient involvement, and no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11068718
• MDR Text Key: 224597678
• Report Number: 2249723-2020-02229
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/06/2021; 03/12/2021
• Supplement Dates FDA Received: 01/20/2021; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1