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 Appropriate Term/Code Not Available (3191)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit is alarming.There is no patient involvement.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4,d9,e1(site country),g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions),h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) unit is alarming.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He states that, the touchscreen wasn't working.He cleaned it and still didn't work.He swapped displays and was able to get "low vacuum" and "gas gain in iab circuit" alarm messages.Replaced 9v daughter board battery with customer supplied one.Replaced the helium regulator and high pressure transducer.Replaced executive processor due to age.Installed b.17 software.Replaced the video generator board and touch screen which resolved the display issue.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.Performed visual inspection of all parts received and following parts look to be in condition.Fat received pn: 0040-00-0456 sn: na video gen.Boards kit, pn: 0012-00-1787 sn: na cable harness(kit), pn: 0670-00-0841 sn: (b)(6) 15_swemco upper video gen.Board(kit), pn: 0670-00-0781 sn: (b)(6) 24_nbs video gen.Board main(kit), pn: 0160-00-0123 sn: (b)(6) touchscreen assy.Performed visual inspection of below parts and observed corrosion on high pressure helium regulator.Please see attached pictures.It probably cause of alarm gas gain in iab circuit message.Due to corrosion this part cannot be investigated further by fat dept., it will be harmful to test fixture.I chose itd root cause grid for these parts.Pn: 0103-00-0637 sn: (b)(6) high pres.Helium regulator pn: 0682-00-0092-01 sn: (b)(6) high pressure transducer installed the video gen.Boards kit, touchscreen assy, 12.1¿¿ into the cardiosave test fixture sn (b)(6) and tested together and separately to the factory specifications per pn 0002-07-d016 revision e and the cardiosave service manual pn 0070-00-0639 revision r.The failure analysis and testing department could not verify the failure for video gen.Boards kit.Video gen.Boards (kit) passed testing.I chose not confirmed root cause grid for pn: 0012-00-1787.The following part is no longer going back to the supplier, as the supplier is unable to test this part due to being too old of a revision, and thus has rejected it.Investigation is complete.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.

• 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: 15654352
• MDR Text Key: 304089821
• Report Number: 2249723-2022-02743
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1