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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit but was unable to duplicate the customer's reported issue.Upon review of the iabp log files, the stm observed fault code #64 logged once.As per the service manual, the stm cleaned the power supply fan then powered on the iabp unit several times without issue.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during use on a patient in the intensive care unit (icu), the cs300 intra-aortic balloon pump (iabp) generated a system 7 malfunction.It was later clarified that the customer had observed a maintenance required code #7.The iabp unit was swapped out with another iabp unit.There was no patient harm, serious injury or adverse event reported.

Event Description

It was reported that during use on a patient in the intensive care unit (icu), the cs300 intra-aortic balloon pump (iabp) generated a system 7 malfunction.It was later clarified that the customer had observed a maintenance required code #7.The iabp unit was swapped out with another iabp unit.There was no patient harm, serious injury or adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.

• 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: 10479544
• MDR Text Key: 205260308
• Report Number: 2249723-2020-01404
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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: Health Professional
• 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: 08/12/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 91