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 Failure to Read Input Signal (1581)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) tracing has disappeared on unit intermittently.Screen is still working.Patient involved, there was no patient harm reported.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9(device available for eval, return to manufacture date), h6(type of investigation, investigation findings, component codes and investigation conclusions).A getinge field service engineer evaluated stated that customer saw the waveforms go flat but the information even though not displayed was being processed and the patient was still being assisted.After speaking to the bu tech support we decided that the video board should be replaced.Replaced video board and turned in with a trainer for 3 days without failure.Returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Received the following parts associated with this complaint: (kit, display monitor to video gen board).These parts were received with a reported failure of the waveforms being flat.The fat performed a visual inspection and found the parts to be in good condition.The fat installed the parts in cardiosave test fixture and tested the parts to factory specifications per the cardiosave service manual part number (b)(4) revision r.These parts were not able to take the software and were therefore unable to be tested.Fat verified these pars to be faulty but no root cause defined.Due to the boards not being rohs compliant, they cannot be sent to a supplier for failure analysis.Retaining the parts in the failure analysis and testing department per procedure number (b)(4) rev.Aq.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: 18402959
• MDR Text Key: 331507365
• Report Number: 2249723-2023-05513
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 159 KG