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

Model Number N/A

Device Problem Erratic or Intermittent Display (1182)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a "flickering screen" issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, e1 (initial reporter & event site email), g4, g7, h2, h6 (evaluation method codes), h10, h11.Corrected fields: h6 (patient code, evaluation method,evaluation result, and evaluation conclusion codes), h10.The full name of the initial reporter in block e1 was shortened due to field character limit; the full name is (b)(6).A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the lcd screen, keypad controller board, coiled cable, and video receiver card.The iabp was tested to ensure proper functioning and all worked as it should.The fse had also performed a preventive maintenance (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.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a "flickering screen" issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 12 month product complaint trend data for the period (jan-2020 to dec-2020) was reviewed.There were no triggers identified for the review period.

• 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: 11065177
• MDR Text Key: 224598558
• Report Number: 2249723-2020-02209
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

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: 02/01/2021; 07/27/2021
• Supplement Dates FDA Received: 02/24/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKWOWN.