MAUDE Adverse Event Report: PHILIPS HEALTHCARE ACHIEVA 1.5T NEW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781296

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing on this event.When the investigation is completed a follow up will be sent to the fda.

Event Description

Philips received a report from a customer that a patient was scanned on an achieva 1.5t mr system with the quad head coil using a gamma knife positioning frame.The patient sustained a blister on the forehead.

Manufacturer Narrative

"response to rfa request from fda 20190131.Pdf." submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.Attachment: (b)(4).

Manufacturer Narrative

Based on the provided information and tests performed on site there is no indication of a malfunction of the mr system, coil or gamma knife positioning frame used.This and similar incidents have been thoroughly investigated by a joint philips and elekta team, in cooperation with the local clinical radiation therapy team of the guiyang site.Amongst others, a site visit has been conducted together with elekta to observe the sites workflow, the logfiles of incidents were reviewed, the system was tested and a similar elekta frame was tested in best.Main results: patient injuries do not correlate with high rf dose examinations.There is no apparent placement of any parts of the frame at the location of the injuries.In a clinical setting 'no temperature rise' was observed, using a temperature scanner, that can explain any skin reaction on the forehead.It is concluded that the reported injuries are not related to the mr system nor the elekta gamma knife positioning frame.It is suspected that the injuries are caused by specific local actions.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ACHIEVA 1.5T NEW
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8141144
• MDR Text Key: 129572760
• Report Number: 3003768277-2018-00095
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781296
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 53