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

Model Number 0998-00-0800-52

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance, the cardiosave intra-aortic balloon pump (iabp) safety disk replacement required.

Manufacturer Narrative

This report is being cancelled as it is related to a routine safety disk replacement; there was no malfunction with the unit.Revert all sections to blank : b.Adverse event or product problem.D.Suspect medical device.E.Initial reporter.G.All manufacturers.H.Device manufacturers only.

Event Description

This report is being cancelled as it is related to a routine safety disk replacement; there was no malfunction with the unit.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 19216899
• MDR Text Key: 341471859
• Report Number: 2249723-2024-01777
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/15/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1