MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; IZI

Model Number 722012

Device Problems Bent (1059); Device Stops Intermittently (1599)

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

Event Type  malfunction  

Event Description

Philips received a complaint from a customer that a bent footswitch worked intermittently.The customer has a bent footswitch that has caused intermittent problems.

Manufacturer Narrative

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

• Brand Name: ALLURA XPER FD20
• Type of Device: IZI
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dominic siewko ; 3000 minuteman rd, ms 4-135; andover, MA 01810 ; 9786597936
• MDR Report Key: 3815397
• MDR Text Key: 4447868
• Report Number: 3003768277-2014-00026
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/15/2014

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: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 03/27/2014
• 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