MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number INGENIA 3.0T CX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It has been reported to philips that the patient suspects of vaginal burning.Philips has started an investigation of this complaint.

Manufacturer Narrative

Conclusion: based on the information available and the testing conducted, this incident was not caused by system malfunction (no system hazard).No definitive explanation for alleged blistering can be provided.A review of the risk management file was performed and this incident reported cannot be considered being associated with the mr examination by ingenia 3.0t cx for the following reasons from a clinical perspective at this point: potential scenarios for this case are related to either skin-to-skin contact, skin-bore wall contact, or antenna effects.Some publications have reported thigh-thigh loop, or right hand-pelvis contact, but the blistering was not located in the exact area.Also, the patient was rather slim (bmi19.6) for thigh-thigh loop; any skin contacts were not observed and isolation was secured by own patient's clothes during scanning.Detailed information including the size and overall area of blistering was not provided by the patient.At this point we cannot further evaluate relatedness of this incident to the mr machine without additional information about patient¿s conditions or materials can cause antenna effects, such as local medication or cream in the area concerned, etc.There was no indication of a system malfunction including any visual irregularities or artifacts in the images taken during the heating event tested by a fse, which suggested that there were no specific materials/substances identified on images that can cause image artifacts and antenna effects.A clinical assessment review was performed and the additional information contained indicates this reported injury meets the criteria for serious injury as the injury was described as a blistering on the patient's vagina (genitals).The patient did not require additional medical treatment and declined to provide photos of the area for the investigation.

• Brand Name: INGENIA 3.0T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15937023
• MDR Text Key: 305039571
• Report Number: 3003768277-2022-01405
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: 884838068452
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA 3.0T CX
• Device Catalogue Number: 781271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 50 KG