MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAD CONNECTOR CABLE; DEFIBRILLATOR

Model Number	M3508A
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported there was a patient burn after cardioversion.The device was in use on a patient.Additional details have been requested.
Additional Manufacturer Narrative
The available details indicate that the reported issue was related to the heartstart hands-free cable.The patient experienced first-degree burns over 4-4.5% and did not require medical intervention and was discharged; this does not meet the definition of a life-threatening or serious injury.First and second-degree burns are known and common risks inherent in defibrillator use during a cardioversion procedure.As such, this complaint is being updated from a serious injury to a product problem.The philips heartstart adult pads instructions for use (ifu) provide the following warning: "misuse or misapplication of any electrode pad may result in patient burns or ineffective therapy.Note: reddening of the skin is normal." a new cable was installed and the device was returned to full functionality.
Event or Problem Description
It was reported there was a patient burn sign after cardioversion.The device was in use on a patient.

• Brand Name: PAD CONNECTOR CABLE
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16301857
• Report Number: 3030677-2023-00515
• Device Sequence Number: 7049179
• Product Code: MKJ
• UDI-Device Identifier: 20884838002757
• UDI-Public: 20884838002757
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: M3508A
• Device Catalogue Number: M3508A
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening
• Patient Sex: Unknown