MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722008

Device Problem Improper Device Output (2953)

Patient Problem Hair Loss (1877)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.(b)(4).

Event Description

Philips received a complaint from a customer that there were concerns of overexposure due to a patient experiencing hair loss.The in-house physicist of the hospital checked the system according the philips instructions and determined it was actually operating within specifications and that the issue was caused by long exposure times.Philips had previously checked the system on (b)(6) and performed full calibrations.Patient b had to undergo three procedures; (b)(6).

Manufacturer Narrative

Philips investigated this complaint and found that the system was operating within manufacturers' specifications and that the issue was related to the procedure.The customer confirmed that the dose was a result of the physician exposing the patient for an extended period of time and due to a very small area of interest in the patients¿ cranial area.Since there was no system malfunction, the system was returned to the customer in working order.(b)(4).

• Brand Name: ALLURA XPER FD20 BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5177593
• MDR Text Key: 29244074
• Report Number: 3003768277-2015-00089
• Device Sequence Number: 1
• Product Code: OWB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 722008
• Device Catalogue Number: 722008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other