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

Catalog 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
Event or Problem Description
This report is based on information provided by philips customer support personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the philips heartstart hands-free cable, indicating that a patient sustained a burn sign during a cardioversion procedure involving the cable, and burns are a known side effect of cardioversion.The device was in use on a patient.This complaint was logged against the heartstart mrx als monitor (m3536a).
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." based on the available information, the cause of the cable malfunction could not be determined, as the serial number and other data about the cable were not available.Based on the information available, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Based on the information provided, it is unclear what caused the heartstart hands-free cable to malfunction, leading to the burn sign.Nevertheless, a new cable was installed, the device was returned to full functionality, and no further complaints were reported.If additional information is received, the complaint file will be reopened.

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17718729
• Report Number: 3030677-2023-03589
• Device Sequence Number: 7289072
• Product Code: MKJ
• UDI-Device Identifier: 20884838002757
• UDI-Public: 20884838002757
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: IS
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M3508A
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2023
• 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
• Patient Sex: Unknown