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 Problems Radiation Burn (1755); Partial thickness (Second Degree) Burn (2694)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

The investigation is still 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 related to a patient heating incident with an achieva 1.5t mr system.The patient sustained a 2nd to 3rd degree blister on each shoulder after an mri examination.It was indicated that the patient was scanned in her own dress with some kind of metallic beads.

Manufacturer Narrative

Based on the provided information and test performed on site there is no indication of a malfunction of the mr system or coil used.It is concluded that the injuries on the patients shoulder were caused by the patient¿s own clothing (dress) worn during the mr examination.The dress had metallic threads on the location of the affected skin.No further contributing factors were observed.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7108296
• MDR Text Key: 94515570
• Report Number: 3003768277-2017-00105
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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
• Patient Age: 45 YR
• Patient Weight: 60