MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS QUADTRODE MRI ECG PAD,25/BOX

Model Number 989803179031

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the customer had a patient who had a sedated mri of his brain on friday, the 11th of february.This was a pretty quick scan and they used the last of the invivo quad ekg pads.The parent of the patient called to report the patient has what looks like burns on their chest.

Event Description

It was reported the patient was experiencing migraines.The patient had a sedated mri of his brain on friday, the 11th of february.This was a pretty quick scan and they used the last of the invivo quad ekg pads.The parent of the patient called to report the patient has what looks like burns on their chest.The patient saw their pediatrician who diagnosed as an allergic reaction.The patient was treated with motrin and was prescribed a cream.

Manufacturer Narrative

The product associated with the reported event was disposed of, therefore no evaluation/analysis could be performed.As evaluation/analysis was unable to be performed, the cause of the event could not be determined.The customer indicated to the philips complaint investigator that bjc did not prepare the patient¿s skin and when the patient arrived bjc would place the patient under sedation with propofol, the pad would be placed directly on the patient¿s chest and the leads would be connected.Bjc confirmed that the patient underwent a safety screening with the family before the scheduled procedure where the staff of bjc answered any mri specific questions that the patient¿s family may have had.A nurse practitioner and or an anesthesiologist at bjc then performed a safety screening to discuss the anesthesia risks involved with the procedure with the family.Finally, the surgery staff at bjc evaluated the patient for any known allergies, including any allergies to adhesives, foods, drugs, etc.It was reported the patient had no known allergies.Bjc confirmed that the mri procedure was a quick scan and lasted fifty minutes.Following the scheduled mri procedure, the parent of the patient contacted bjc the same day and stated that the patient had reacted and thought that the patient had experienced a burn.An image was forwarded to bjc by the patient¿s parents to evaluate the alleged site reaction phenomenon.Bjc suspected that the alleged burn appeared to look more like a site reaction to the pad adhesive.The mother of the patient was advised to treat the patient with motrin until the patient could present to a pediatrician.The patient¿s mother later contacted bjc and reported that after seeing a pediatrician, the patient was diagnosed with having an allergic reaction and a cream was prescribed to treat the patient.Bjc did indicate to the philips complaint investigator that the philips pads that were being used in this procedure were originally provided to bjc as samples and that the staff of bjc preferred to use them as they were more manageable.The customer confirmed that they had since run out of the philips pads and had switched to cardinal brand pads.A letter was sent to bjc with the results of the investigation, which included the contents of the pad adhesive and the testing standard to which these devices are submitted.Philips 989803179031, quadtrode mri ecg pad, 25/box are manufactured to pass iso 10993-1 and iso 10993-5 biocompatibility testing and iso 10993-10 testing for skin irritation and sensitization.Furthermore, bjc requested information related to the adhesives used in the philips 989803179031, quadtrode pads.A philips product industrialization engineer (pie) confirmed that the complaint device product adhesive was formulated for sustained contact with the human skin and had been tested for hypoallergenic properties by private bio-medical laboratories.The philips quadtrode pads consist of a cross linked 1.6mm polyethylene foam coated on one side with mp597, which is an acrylic based, hypoallergenic pressure sensitive adhesive which is protected by an 80gr calendered paper release liner.

• Brand Name: QUADTRODE MRI ECG PAD,25/BOX
• Type of Device: QUADTRODE MRI ECG PAD,25/BOX
• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13667377
• MDR Text Key: 286580492
• Report Number: 1051786-2022-00015
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 20884838029525
• UDI-Public: 20884838029525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803179031
• Device Catalogue Number: 989803179031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 58 KG