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

Model Number 0998-00-0800-55

Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to reproduce the reported issue.The fse found that the touch screen was still not working correctly and the buttons had to be pressed repeatedly for a response.Furthermore, the fse found related fault codes #63 and # 64 recorded in the logs.No visible mechanical damages of the panel was observed.The fse ordered a replacement touchscreen assembly, 12.1¿, and upon receipt, repairs can continue.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.The full event site name is (b)(6).

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) touchscreen panel was very rigid in responding and required the end user to press the buttons repeatedly.It was also reported that as a result of the touchscreen panel issue, calibration of the touch screen had to be performed several times until it was completed.Additionally, electrical test failure #6 was reported to have appeared after start-up.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The fse resolved the reported issue by replacing the touchscreen assembly, 12.1¿, seal, display.125 x.200 x 5.0, seal,display.030 x.200 x 2.2, seal,display.030 x.200 x 9.6, seal dip,.059 x100 x7.45, and seal dip,.059 x100 x10.07.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/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: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11731950
• MDR Text Key: 247561450
• Report Number: 2249723-2021-00877
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1