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 Failure to Zero (1683); Inadequate User Interface (2958)

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

Event Date 05/05/2023

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 unable to zero due to touch screen.

Event Description

It was reported during a routine check, the cardiosave intra-aortic balloon pump (iabp) unit is unable to zero due to touch screen.There was no patent involved.

Manufacturer Narrative

A getinge field service engineer (fse) stated that device received damage to the top display bezel.Hinges showed signs of irreparable damage.Top display bezel when closed was moved 1/16th of an inch forward instead of being fush with the lower bezel.Upper lcd had a line in the display.Fse replaced assembly,top level display.Performed a full function and calibration check.Device operating within manufacturer specifications.Unit returned to customer and cleared for clinical use.

Event Description

N/a.

• 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: 16938607
• MDR Text Key: 315290029
• Report Number: 2249723-2023-02363
• 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,Followup
• Report Date: 04/01/2024

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: 05/05/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 03/29/2024
• Supplement Dates FDA Received: 07/11/2023; 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1