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 Overheating of Device (1437); Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed for over temperature and shut down, and would not restart.Patient was transitioned to another iabp.There was no patient harm or injury reported.

Manufacturer Narrative

Updated fields: h6 ( type of investigation, investigation findings, investigation conclusion).Additional fields: e1 (event site address line 2: (b)(6)).It was reported that the cardiosave intra-aortic balloon pump (iabp) overheated during procedure, alarming high temp unable to restart.A getinge field service engineer (fse) stated, after looking through the logs, found compressor adjustments, replaced compressor and temp sensor threaded probe, functionality, and safety checks passed factory specifications.Released for clinical service upon completion.There was patient involved but no harm.The defective components were received for further investigation.The failure analysis and testing dept.Received part and with a reported unit failure of overheating and the system shutting off.The fat performed a visual inspection and found the part to be in good condition.The fat installed in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual.Ran the unit for 3 hours with no issues.The fat installed in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual.Ran the unit for 3 hours with no issues.Fat was not able to verify the reported failure.Retaining the parts in the failure analysis and testing department per procedure.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• 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: 18074912
• MDR Text Key: 327423960
• Report Number: 2249723-2023-04750
• 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: 04/25/2024

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?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1