MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722010

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 10/01/2015

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 the customer in which they stated that the air kerma was too high.The patient received a radiation dose of 2,15gy during the procedure.The exposure time was 4.2 min fluoro time.The customer used a frame rate of 30 frames per second.The system was checked by a philips field service engineer and he found that is was working according specifications.

Manufacturer Narrative

A philips field service engineer tested the system and found that the system was working within specification.After talking to a hospital technician the field service engineer determined that the doctor performing the procedure used 30 frames per second by mistake during the procedure, which led to the high patient dose.In order to prevent reoccurrence of the issue the doctor was made aware of his mistake.The issue had no impact on the patient and no patient or user harm was reported by the customer.(b)(4).

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 5180665
• MDR Text Key: 29364432
• Report Number: 3003768277-2015-00091
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• 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: 10/01/2015

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• 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