MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0479-53

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) units monitor flickers on and off for a few seconds.

Manufacturer Narrative

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

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) units monitor flickers on and off for a few seconds.There was no patient harm reported.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10.A getinge field service engineer (fse) verified issue, replaced pcb inverter, dc to ac (pcb,inverter,dc to ac).Performed safety, calibration, and functionality checks passed factory specifications.Returned to clinical service upon completion.The defective components were received for further investigation.The failure analysis and testing department received the following part associated with this complaint: pcb, inverter.This part was received with a reported unit failure message of monitor was flickering.Performed visual inspection of this part received and part looks to be in good condition.Installed the pcb, inverter into the cs300 test fixture and tested to the factory specifications per pn: 0070-00-0689 revision w cs300 service manual.The failure analysis and testing department performed display tests and passed.The failure analysis and testing department could not verify the failure message of monitor flickering.Pcb, inverter passed testing.Retaining pcb, inverter in the fat dept.The non-conformances with the returned components were not identified.However, the root cause or the most probable root cause is not confirmed.

Event Description

N/a.

• 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: 17797301
• MDR Text Key: 324010988
• Report Number: 2249723-2023-04160
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,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: 0998-00-0479-53
• Device Catalogue Number: 0998-00-0479-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/29/2023; 04/25/2024
• Supplement Dates FDA Received: 11/01/2023; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.