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

Model Number 0998-00-0800

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Two out of three of our intra-aortic balloon pumps used for transport are displaying a disk error.The manufacturer says there is a safety disk that needs to be replaced, but they don't know when the parts will be in.We have been trying to obtain an answer from getinge as to whether the pumps are safe for use, but have not gotten a definitive response.We have removed our pumps from service.Manufacturer response for intra-aortic balloon pump, cardiosave (per site reporter).The parts are backordered.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 15592648
• MDR Text Key: 301644025
• Report Number: 15592648
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1