MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Block e1 event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) does not turn on.The fault did not cause damage to operators/patients.

Manufacturer Narrative

A getinge field service engineer(fse) evaluated the unit.The console unit (rescue) was correctly attached to the cart (hospital trolley.Visual check of the icons on the status of functionality in hybrid or rescue mode and of the battery charging system.Tests with cardiosave trainer simulator.Operational tests carried out with positive results.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 18495355
• MDR Text Key: 333157870
• Report Number: 2249723-2024-00098
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.