MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS HEARTSTART SMART PADS III; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	SMART PADS III
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Noted red skin burn type marks to patient's right upper and lower chest where pads were in place.Per philips, need to determine if a new case number is needed or if this can be added to an existing complaint related to pad use.
Event or Problem Description
Noted red skin burn type marks to patient's right upper and lower chest where pads were in place.Per philips, need to determine if a new case number is needed or if this can be added to an existing complaint related to pad use.

• Brand Name: PHILIPS HEARTSTART SMART PADS III
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 15100 woodinville-redmond road; bldg a, suite 300; woodinville WA 98072
• MDR Report Key: 16512000
• Report Number: 16512000
• Device Sequence Number: 6367024
• Product Code: MKJ
• UDI-Device Identifier: 00884838023765
• UDI-Public: (01)00884838023765(17)250405(10)221005-4034
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023
• Report Date (Section F): 02/28/2023

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 Model Number: SMART PADS III
• Device Catalogue Number: 989803149981
• Device Lot Number: 221005-4034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White
• Date Report Sent to FDA: 02/28/2023