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

Catalog Number 13665749

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2016

Event Type  malfunction  

Event Description

When starting pump, error message came up on screen "unable to pump".Attempted three times and received the same message.The pump was changed out and then worked properly.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): MAQUET DATASCOPE CORP.; 15 law dr; fairfield NJ 07004
• MDR Report Key: 6043704
• MDR Text Key: 57971200
• Report Number: 6043704
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 13665749
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR