MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722012

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/17/2014

Event Type  Injury  

Event Description

Philips received a complaint from a customer that the system went down during a procedure with a patient on the table, table froze.The patient had to be moved to another room.

Manufacturer Narrative

(b)(4).When investigation is completed a follow up report will be sent to the fda.

• Brand Name: ALLURA XPER FD20
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4 - 6; best 5680 ; NL 5680
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4359766
• MDR Text Key: 5118273
• Report Number: 3004022368-2014-00005
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention