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 Power Up (1476)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.Due to character restrictions in block e1 initial reporter : (b)(6).

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit system will not boot up.

Manufacturer Narrative

Updated fields: h6 (type of investigation, investigation findings, component codes and investigation conclusions).Corrected fields: h6 (health effect ¿ clinical & impact code).A getinge field service engineer (fse) investigated the customer's complaint confirmed unit will not boot up in clinical mode, when unit was turned on just has a spinning wheel.Fse was able to get into the maintenance menu but there were no faults or error codes.Replaced pcba, video generator.Reassembled the unit and turned unit on but it needed the software updated , after update unit started up as it should , ran unit thru a complete calibration and electrical safety tests and all meets factory specifications.Ran unit on test balloon with no issues,unit was returned to customer.

Event Description

It was reported that during start up of unit, the cardiosave intra-aortic balloon pump (iabp) unit system will not boot up.There was no patient involvement.

• 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: 18419805
• MDR Text Key: 331622526
• Report Number: 2249723-2023-05529
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.