MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ECG ELECTRODES

Model Number	3 LEADS SET DISPOSABLE, BEDSIDE IEC RD
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/17/2022
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 to philips that the electrode l of the ecg cable began to burn the patient.The device was in use at time of event, a minor burn was reported.
Additional Manufacturer Narrative
The device was returned to philips.Visual inspection of the lead set found that the lead set has burn damaged on wire for the yellow grabber.It cannot be confirmed if the cable is fatigued, or damage was caused by tension on the lead set.The lead set could not be functionally due to hazard of exposed wire.The customer has ordered the replacement part to resolve the issue.The device will be held in the mcs lab for further review if required.
Event or Problem Description
It was reported to philips that the electrode l of the ecg cable began to burn the patient.The device was in use at time of event, a minor burn was reported.
Additional Manufacturer Narrative
This report was updated as part of a retrospective review based on the available information.
Event or Problem Description
It was reported while monitoring ecg, the patient developed a burn from the ecg cable.The burn was described as minor, for which unknown medical attention was provided.Images of the burn damaged ecg cable and the burn on the patient's skin were received.No additional information was provided.

• Brand Name: ECG ELECTRODES
• Common Device Name: ECG ELECTRODES
• 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: deborah currlin ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14620967
• Report Number: 1218950-2022-00461
• Device Sequence Number: 20118964
• Product Code: DSA
• UDI-Device Identifier: 20884838075720
• UDI-Public: (01)20884838075720(10)0420
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110287
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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 Model Number: 3 LEADS SET DISPOSABLE, BEDSIDE IEC RD
• Device Catalogue Number: 989803174201
• Device Lot Number: 0420
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 05/13/2025
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/08/2022; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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 Sex: Unknown