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

Catalog Number 0684-00-0296-01U

Device Problems Pumping Stopped (1503); Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2016

Event Type  malfunction  

Event Description

Patient being transported from cath lab post procedure to icu.The intra-aortic balloon pump shut down as patient's bed was being rolled off elevator.Attempts to restart pump were unsuccessful.Second pump was brought to icu and attached.Pump functioned appropriately.The disposable catheter continued to function appropriately.It was removed and discarded the next day.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): MAQUET DATASCOPE
• MDR Report Key: 5758640
• MDR Text Key: 48438183
• Report Number: 5758640
• 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: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000020908
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 91