MAUDE Adverse Event Report: GENTINGE / DATASCOPE CORP SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01U

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2021

Event Type  malfunction  

Event Description

Connected balloon catheter to balloon pump.Balloon pump read fiber optic error.Rechecked connection and still read error.Replaced with different balloon pump catheter and new device worked correctly.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GENTINGE / DATASCOPE CORP; 15 law drive; fairfield NJ 07004
• MDR Report Key: 12631250
• MDR Text Key: 276395958
• Report Number: 12631250
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

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: No Information
• Device Model Number: 0684-00-0470-01U
• Device Catalogue Number: 0684-00-0470-01U
• Device Lot Number: 3000154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 86