MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) presents several defects related to charging and discharge of batteries, presenting functions lockdown.
Event or Problem Description
It was reported that during tests by hospital engineer the cardiosave intra-aortic balloon pump (iabp) presents several defects related to charging and discharge of batteries, presenting functions lockdown.There was no patient involvement.
Additional Manufacturer Narrative
It was reported that cardiosave intra-aortic balloon pump (iabp) issue with battery charge.Event occurred during tests by the hospital engineer and there was no patient involved.A getinge field service engineer (fse) verified the issue and remarked as several defects related to charging and discharge of batteries.Replacement of the solenoid control board and the executive processor board.When exchanging the executive processor board the equipment alarmed (start test failure cod.N°10) when returned the executive processor board worked perfectly.With this, the solenoid control board was replaced.Tests were carried out in service mode and the equipment was cyclist for more than hours and it did not show a defect.Equipment tested and released for use.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h5).
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE J PLUG
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18013857
• Report Number: 2249723-2023-04622
• Device Sequence Number: 7314094
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117(21)CB342653J1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 04/03/2024; 10/01/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/01/2023; 04/10/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown