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

Device Problem No Display/Image (1183)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that ,while waiting with the power turned on, the cardiosave intra-aortic balloon pump (iabp) touch panel side was not displayed.Although it was booting, the monitor screen was not displayed dark, and when the power was turned off and turned on again, the problem disappeared.

Event Description

It was reported that during post use inspection, while waiting with the power turned on the cardiosave intra-aortic balloon pump (iabp) touch panel side was not displayed.Although it was booting, the monitor screen was not displayed dark and when the power was turned off and turned on again, the problem disappeared.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.A communication error from the video generator board was considered and as precaution, the fse replaced the display monitor to video gen board.The fse completed full calibration, functional testing, and safety check to factory specification.The unit passed all tests performed and was returned to the customer in good working conditions.

• 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: 17558188
• MDR Text Key: 321375674
• Report Number: 2249723-2023-03724
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 12/11/2023
• Supplement Dates FDA Received: 09/06/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.