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

Model Number 0998-00-0800-53

Device Problem Failure to Sense (1559)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to investigate and evaluate the iabp unit.The fse was informed that the customer replaced the touchscreen which did not resolve the issue.After further troubleshooting, the fse found that there was not another touchscreen panel.However, the fse found that the safety disk leak test, as well as the drive assembly test were also failing.Therefore, the fse resolved the issues by replacing the drive assembly, and also replaced the defective pneumatic module cable and reseated it to the backplane.The fse performed calibration, functional and safety checks to meet factory specifications, without any further failures.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated is (b)(6).

Event Description

During a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the customer reported to the fse that the touch panel of the cardiosave intra-aortic balloon pump (iabp) was not working properly, where it did not allow 30 psi pressure calibration to complete.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11 corrected field: d5, e1 (initial reporter, event site telephone, event site email), e2, e3, e4, g1 (contact person ¿ mfg site), g3 (health professional, user facility should not be included).The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6), biomedical engineer.

• Brand Name: CARDIOSAVE HYBRID TYPE B 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12606811
• MDR Text Key: 280158506
• Report Number: 2249723-2021-02321
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.