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

Model Number	781396
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Date of Event	05/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing on this event.When the investigation is completed a follow-up will sent to the fda.
Event or Problem Description
Philips received a report from a customer related to a patient heating incident with an ingenia 1.5t mr system.A patient was scanned for an mri examination.After the examination 2nd to 3rd degree blistering (size 8x10 cm) was reported.
Additional 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 that contributed to the event.The injury on the patient¿s right arm is consistent with heating injuries caused by skin-to-bore contact.It was stated that the patient was touching the bore and no padding was used to prevent body-to-bore contact.Contributing factors in this case identified are: the patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The patient had diabetes, which indicates an impaired thermoregulation.

• Brand Name: INGENIA 1.5T
• Common Device Name: 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: 7586492
• Report Number: 3003768277-2018-00041
• Device Sequence Number: 1415170
• Product Code: LNH
• Combination Product (Y/N): N
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2018

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
• Operator of Device: Health Professional
• Device Model Number: 781396
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 95