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 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.The full name of the initial reporter is (b)(6).

Event Description

It was reported that while performing the precheck (before handing over the unit to concern user department from biomedical department), the cs300 intra-aortic balloon pump (iabp) had electrical failure code #50 while switching the unit on.There was no patient involvement, and no adverse event reported.After inspecting the unit motor control pcb is been suspected, and the same spare was ordered for replacement, awaiting to receive the spare.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.After inspecting the iabp's motor control board the fse found it to be faulty, and the same spare was ordered and replaced to fix the issue.The fse 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.

Event Description

It was reported that while performing the pre-check (before handing over the unit to concern user department from biomedical department), the cs300 intra-aortic balloon pump (iabp) had an electrical failure code #50 while switching the unit on, with a continuous beep.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that while performing the precheck (before handing over the unit to concern user department from biomedical department), the cs300 intra-aortic balloon pump (iabp) had an electrical failure code #50 while switching the unit on, with a continuous beep.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: 11064445
• MDR Text Key: 223454084
• Report Number: 2249723-2020-02203
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1