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

Model Number	M3536A
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	Serious Injury
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 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 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.If additional information is received, the complaint file will be reopened.H3 other text : philips was unable to obtain additional details.

• 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: 17716074
• Report Number: 3030677-2023-03587
• Device Sequence Number: 15140782
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• 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