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 sign after cardioversion.The device was in use on a patient.Additional details have been requested.
Additional Manufacturer Narrative
The patient had a burn sign; however, philips was unable to obtain additional details regarding the degree of the burn and the treatment of the burn.Multiple requests were made; however, no information was able to be provided by the customer.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.Based on the information provided, it is unclear what caused the heartstart hands-free cable to malfunction, leading to the burn sign.If additional information is received, the complaint file will be reopened.H3 other text : multiple requests were made; however, no information was able to be provided by the customer.
Event or Problem Description
It was reported there was a patient burn sign after cardioversion.The device was in use on a patient.
Additional Manufacturer Narrative
The patient had a burn sign; however, philips was unable to obtain additional details regarding the degree of the burn and the treatment of the burn.Multiple requests were made; however, no information was able to be provided by the customer.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 device was returned to service after new cable was installed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Correction: evaluation results and conclusion code have been updated.Correction: this report has been updated from serious injury to product problem.Correction: model number updated from m3508a cable to heartstart mrx m3536a.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.A first-degree burn was reported, which is considered a minor injury.

• 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: 16522132
• Report Number: 3030677-2023-01046
• Device Sequence Number: 14032529
• 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,Followup,Followup
• Report Date (Section B): 09/28/2024

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; 09/27/2024
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/05/2023; 09/27/2024
• 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