MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR400)

Model Number	866185
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that there was an issue with the invasive blood pressure line in which the patient was burned while using the equipment.Additional information has been requested in order to determine the extent of the patient's burns and if the alleged burns required intervention to prevent serious injury.The complaint device was in use at the time of the alleged event.The patient allegedly came into contact with the device and was burned in the process.
Additional Manufacturer Narrative
H6: corrected coding.A philips field service engineer (fse) went to the customer site.Several good faith efforts were made to determine how the complaint device was evaluated and what resolution was offered to the customer following this event.Responses were provided by the philips product specialist who communicated with the senior modality manager-mri, mr safety at (b)(6) in a virtual microsoft teams meeting that occurred on (b)(6) 2022.The philips product specialist was also dispatched to an onsite meeting at (b)(6) on (b)(6) 2022.During these meetings it was confirmed by the customer that during clinical use, a patient had suffered a full thickness burn while using a third-party edwards truwave pressure monitoring kit while being monitored by a philips 866185, expression model mr400 mri patient monitoring system.The customer confirmed that the seventy-five-year-old, female patient weighing seventy-five kilometers had presented to (b)(6) for a brain, cervical, thoracic, and lumbar spine exam without contrast.The patient was scanned feet first in a supine position, and her arms were positioned at her side and were not touching the bore.The burn had occurred on her left arm in the antecubital area.The customer confirmed to the philips product specialist that the patient was wearing a hospital-provided gown and no metal was present.The patient did not have any tattoos and was on a ventilator.During the scheduled mri scanning procedure, the customer confirmed with the philips product specialist that the tubing and transducer had been looped on the edwards truwave pressure monitoring kit on the patient's skin and that the fluid and transducer of the kit conducted heat, which caused the patient's burns.Despite several attempts to procure additional information on the patient's condition following this incident, no response was provided to aid in the investigation.The philips fse confirmed that the philips 866185, expression model mr400 mri patient monitoring system was tested and was functioning as intended.The customer indicated to the philips product specialist that the philips device did not cause or contribute to the burns that the patient suffered.No malfunction of the philips device occurred.Based on our investigation, it was determined that the philips 866185, expression model mr400 mri patient monitoring system did not cause or contribute to the burn that was suffered by the patient.The device that was indicated by the customer to have caused or contributed to the patient¿s injury was not manufactured or distributed by philips.Additionally, the customer indicated that unintentional user error may have contributed to the adverse event described in this event, as a result of looping the tubing and transducer on the patient¿s skin during the procedure.
Event or Problem Description
It was reported that there was an issue with the invasive blood pressure line in which the patient was burned while using the equipment.The complaint device was in use at the time of the alleged event.The patient allegedly came into contact with a edwards truwave pressure monitoring kit and was burned in the process.

• Brand Name: EXPRESSION PATIENT MONITOR (MR400)
• Common Device Name: EXPRESSION PATIENT MONITOR (MR400)
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13423994
• Report Number: 1051786-2022-00009
• Device Sequence Number: 17474708
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: 00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866185
• Device Catalogue Number: 866185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 75 KG