MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20

Model Number 722012

Device Problem Insufficient Information (3190)

Patient Problem Radiation Burn (1755)

Event Date 06/27/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The field service engineer (fse) troubleshot the system and found that the maximum fluoroscopy dose did not exceed the 10r/min limit and no other problems were detected.

Event Description

Philips received a complaint from a customer that patient were having radiation burns after surgery.The customer indicated that system was inspected by hospital physicist and found no problems with equipment.

• 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: 3778211
• MDR Text Key: 19390821
• Report Number: 3003768277-2014-00030
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• 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: 08/08/2013

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: 08/08/2013
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other