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 Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse) multiple major faults (106, 110, 124 and 137) were found.This report is to document fault #110.The original complaint for fault# 106 has been reported under medwatch report #2249723-2021-02250.There was no patient involvement and no adverse event reported.The original complaint opened (b)(4).

Manufacturer Narrative

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), administrator/supervisor.Testing of actual/suspected device|10: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the front end pcb, replaced the executive processor pcb, replaced the scroll compressor, replaced the drive regulator, and replaced the touchscreen assembly.The fse reloaded b.17 software and replaced the coil cable due to the locking clasp easily lock securely.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Testing of actual/suspected device: the fse replaced the touchscreen assembly and then performed all calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The aware date for the initial mdr submitted should be 2021-11-16.

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse) that the cardiosave intra-aortic balloon pump (iabp) unit's buttons were intermittently not responding.The screen was calibrated but the issue persisted.There was no patient involvement and no adverse event reported.

Manufacturer Narrative

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse) that the cardiosave intra-aortic balloon pump (iabp) unit's buttons were intermittently not responding.The screen was calibrated but the issue persisted.There was no patient involvement and no adverse event reported.Replaced the front end pcb, replaced executive processor pcb, replaced scroll compressor, replaced drive regulator, and replaced the touchscreen assembly.Reloaded b.17 software.Replaced coil cable due locking clasp easily lock securely.Functional tested without any further failures cardiosave iabp services completed.Released 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.The failure analysis and testing dept.Received part pcb,exec processor with a reported unit failure of the cardiosave in a continuous reboot.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed the pcb,exec processor into the cardiosave test fixture and tested the board to factory specifications per procedure number (b)(4) revision d and the cardiosave service manual part number 0070-00-0639 revision r.The failure analysis and testing dept.Performed an autofill and let the cardiosave run to observe if the unit would reboot.After extensive testing and run time the failure analysis and testing dept.Could not replicate the failure the customer experienced of the cardiosave being in continuous reboot.The failure analysis and testing dept.Did not observe the cardiosave rebooting.The board passed testing.Sending the board to the supplier per procedure number (b)(4) rev.An.The board will no longer go back to the supplier.The supplier is unable to perform a proper failure analysis on the board.Retaining the board in the fat per procedure number (b)(4) rev.Ap.

Event Description

N/a.

• 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: 13232006
• MDR Text Key: 288783986
• Report Number: 2249723-2022-00053
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.