MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. MR 5300; SYSTEM NUCLEAR MAGNETIC IMAGING

Model Number	MR 5300
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Event or Problem Description
Philips received a report that a female patient suffered 2nd degree burn to the right elbow with blistering during lumbar and pelvic region exam with ds torso cardiac coil.
Additional Manufacturer Narrative
There is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The patient was positioned with the armrests holding her arms close to the body.When entering the bore it seemed there was no contact with the bore.When talking to the patient about the incident afterwards, she said that her arms rested against the wall of the bore.There was no padding used to prevent contact with the bore wall.The observed blisters can be explained by close contact with the bore wall.Contributing factors to this heating incident are following: the patient was dressed in patient's own clothing, which was dampened and made from 95% viscose, 5% elastane.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 ventilation was not at the highest level (level 3 was used).Level 5 is recommended for high sar scans, it supports the cool down mechanism.3 scans with high sar values (>2 w/kg) were executed (at 2.1 w/kg).High sar scans are a bigger challenge for the cool down mechanism than low sar scans.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.The mr examination room temperature was above the specified value.The heat dissipation is hindered by a high examination room temperature.A lower examination room temperature reduces the risk on burns, since the patient is less likely to sweat.

• Brand Name: MR 5300
• Common Device Name: SYSTEM NUCLEAR MAGNETIC IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 20006452
• Report Number: 3003768277-2024-04567
• Device Sequence Number: 4431433
• Product Code: LNH
• UDI-Device Identifier: 00884838099364
• UDI-Public: 00884838099364
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K223458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: MR 5300
• Device Catalogue Number: 782110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 124 KG