MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	781342
Health Effect - Clinical Code	Swelling (2091)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the provided information and tests performed on site, there is no indication of a malfunction of the mri system or coil used that contributed to the injury.It is concluded that the injury sustained by the patient was caused by contact between the patient¿s hip and the bore covers.Factors which contributed and made the injury progress to a large burn: the thermoregulation of obese patients and patients who are hypertensive is often impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The patient wore polypropylene clothing which may hinder the heat dissipation.No padding was used to avoid body-to-bore contact.No padding was used to avoid skin-to-skin contact.The ventilation was on level 3.Level 5 is recommended for high sar scans, it support the cool down mechanism.
Event or Problem Description
Philips received a report from a customer that a female patient sustained a blister of approximately 4x8 cm on the left hip.Just before the patient had had a lumbar examination on an ingenia 3.0t.

• Brand Name: INGENIA 3.0T
• 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: 7457662
• Report Number: 3003768277-2018-00030
• Device Sequence Number: 16417643
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: (01)00884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: No Information
• Device Model Number: 781342
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: 90