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

Model Number 0998-00-0800-33

Device Problem Circuit Failure (1089)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported that during routine check performed by customer, the cardiosave intra-aortic balloon pump (iabp) after switching the unit on the system is not booting and giving continuous alarm.There was no patient involvement.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Additional information: e1(event site state: (b)(6)).Fse reported that the cardiosave intra-aortic balloon pump (iabp) after switching on unit system is not booting and continuously giving long alarm.Also observe that, after switching on mains supply to unit, cardiosave automatically switching on without pressing power on button.Checked and reset all the connections and boards inside unit.Problem not solved.Unable to enter in service mode.System power management board and solenoid driver board are suspected.Need for testing purpose.Further checking will be done after replacing the same.After that replacing parts resolve the issue.The unit was finally repaired and returned to the customer.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 15188662
• MDR Text Key: 304964254
• Report Number: 2249723-2022-01993
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: 10607567109008
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: Other
• Device Model Number: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.