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 Power Problem (3010)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit is alarming while powered off and plugged into ac power.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

It was reported that the cardiosave intra-aortic balloon pump (iabp) was alarming while powered off and connected to ac power.It was also reported that the issue was a repeated discrepancy and only happened every 4 months and that the customer had to unplug the unit and remove both the battery packs to end the alarming.A getinge field service engineer (fse) was dispatched to investigate the issue.The fse replaced the cart wiring harness and drained both batteries for about 30 minutes.Then, the unit was left plugged in, powered off, and charging.It was later stated that another fse took over the repair.The new fse stated that fault code was found had occurred 43 times.It was also stated that the main manufacturer was able to reproduce the fault code and suggested to replace the solenoid driver pcb.So, the fse replaced the solenoid driver pcb as requested and continued testing the device after replacing it.Then, the fiber optic module started failing and was not being recognized.Then, the fse checked the software revisions and fiso was displaying "x.Xx".With further investigation, the fse discovered a film of an unknown substance in the back of the backplane pcb, where the executive processor and the front end pcb connect to the backplane pcb.The fse stated that the solder joints on the connectors were discolored and questionable and that the substance did not appear to be saline.So, as a precaution, the fse replaced the backplane pcb due to its appearance.Also, it was noted that the backplane pcb could have been the contributor of all the problems.The fse then retested the fiber optic module and issue remained the same and order the part.The fse retested the unit before replaced the part to verify the failure was still there.And noticed that the fiber optic module was no longer failing and the 1.20 rev software returned.The fse replaced the fiber optic module as a precaution.The fse the performed functional tests without any further failures or alarms.The fse reviewed the logs and the logs were clear.The unit services were completed.All safety, calibration, and functionality checks were done to factory specifications.The fse customer with the customer and the customer verified that there were no issues over the weekend.The unit was released to the customer and cleared for clinical use.The final investigation has been completed by failure analysis and testing department.Retaining the "investigated part" in the failure analysis and testing department per procedure.

• 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: 15640590
• MDR Text Key: 304087833
• Report Number: 2249723-2022-02725
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/16/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1