MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ELCTRD,MRI ECG,QUTRD.CV,10/BOX

Model Number	9371A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the patient developed a rash, described as flat, red, and pruritic, which followed the margins of the ecg quatrode patch.The device was in use at time of event.A serious injury of the patient was reported.
Additional Manufacturer Narrative
The cause of the reported problem was confirmed to be the patient¿s hypersensitivity to the conductivity gel, which was unknown until exposed.Based on the ifu, the appropriate choice of electrode in relation to the patients' weight was the neonatal electrode not the standard electrode.Although, the neonatal electrode could not have prevented the allergic reaction, it would have covered a smaller region the patient's chest.The customer claimed they were unable to get the neonatal patches for over a year due to them being on backorder.We were informed by the customer that the device was not available for evaluation.Without the material being returned, we are not able to perform further evaluation.The patient was given zyrtec, hydrocortisone topical 1% cream, and oral cetirizine to treat rash and itchiness for presumed contact dermatitis.The redness eventually decreased with time and treatment.

• Brand Name: ELCTRD,MRI ECG,QUTRD.CV,10/BOX
• Common Device Name: ELCTRD,MRI ECG,QUTRD.CV,10/BOX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16771092
• Report Number: 1218950-2023-00241
• Device Sequence Number: 20429669
• Product Code: MWI
• UDI-Device Identifier: 10884838101927
• UDI-Public: 10884838101927
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K053462
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 9371A
• Device Catalogue Number: 9371A
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/06/2023
• 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: Required Intervention
• Patient Age: 10 MO
• Patient Sex: Female
• Patient Weight: 7 KG