MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA AMBITION X; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	781356
Health Effect - Clinical Codes	Skin Irritation (2076); Skin Inflammation (2443)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still ongoing for 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 (blistering on the right elbow) with a flex coil on an ingenia ambition x mr system.
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.The injury on the patient¿s right elbow is consistent with heating injuries caused by body-to-bore contact.It was reported that the right elbow was in contact with the bore.Contributing factors observed: - in total 4 scans were performed on high sar, of which 3 scans were consecutively executed, allowing no cool down time for the patient.- the patient ventilation was not at the highest level.Level 5 is recommended for high sar scans, it supports the cool down mechanism.- the patient was sedated.The thermoregulation of sedated patients is known to be impaired.The patient was unable to sense or communicate discomfort or pain.- 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 total administered specific energy dose of 2.8 kj/kg exceeded the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.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: INGENIA AMBITION X
• 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: 9472747
• Report Number: 3003768277-2019-00102
• Device Sequence Number: 16832163
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: (01)00884838090040
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 781356
• Device Catalogue Number: 781356
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 41 YR
• Patient Weight: 171