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

Model Number 42017

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

Intra-aortic balloon pump began alarming "connection to helium lost" perfusion was contacted for trouble shooting.Problem did not resolve.Console was promptly exchanged.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10784928
• MDR Text Key: 214595931
• Report Number: 10784928
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 42017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA