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 Problems Circuit Failure (1089); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) unit failed helium leak and backplane/executive predecessor board.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: h10.Additional contact details: person name: (b)(6).Phone number: (b)(6).Email: (b)(6).Occupation: biomedical engineer.It was reported that the cardiosave intra-aortic balloon pump (iabp) leak test failed - unspecified test, backplane board related malfunction.There was no information on patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Fse states that helium leak and boards are not detected by the executive processor board.Resolution: cck while tightening the helium tubing within the cart and replace the power executive board.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.Pcb's in the internal diagnostics.The executive processor board was observed per the cardiosave service manual part number 0070-00-0639 revision q with no visual damage.The failure analysis and testing dept.Installed the executive processor board htc into the cardiosave test fixture and tested the executive processor board to factory specifications per procedure number 0002-07-d016 revision d and the cardiosave service manual part number 0070-00-0639 revision q.The system was verified not to recognize the list of pcb's in the internal diagnostics.See the attached file for reference.System passed all testing and calibration was complete without issue.However the inability to recognize the installed pcb's is a cause for failure.Executive processor board will be held to the fat dept.Per procedure number 0002-07-d008 revision al.The top display assembly was observed per the cardiosave service manual part number 0070-00-0639 revision q with no visual damage.The failure analysis and testing dept.Installed the top display assembly into the cardiosave test fixture and tested the display assembly to factory specifications per procedure number 0002-07-d016 revision d and the cardiosave service manual part number 0070-00-0639 revision q.The fat dept.Verified and observed the horizontal lines across the display during testing.Display assembly will be held in the fat dept.Per procedure number 0002-07-d008 revision al.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 15635607
• MDR Text Key: 306906531
• Report Number: 2249723-2022-02721
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1