MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20

Model Number 722006

Device Problems Bent (1059); Sticking (1597)

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

Event Type  malfunction  

Event Description

Philips received a complaint from a customer that both pedals on the footswitch were bent inward and the fluoroscopy pedal was sticking intermittently.

Manufacturer Narrative

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

• Brand Name: ALLURA XPER FD20
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dominic siewko ; 3000 minuteman road; ms 4-135; andover, MA 01810 ; 9786597936
• MDR Report Key: 3811095
• MDR Text Key: 4384224
• Report Number: 3003768277-2014-00023
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2014

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: Health Professional
• Device Model Number: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1