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

Model Number	SMART PADS III
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Superficial (First Degree) Burn (2685)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Cath lab nurse noted pads were in place and appeared adhered to skin during cath lab patient prep.  during cath lab intervention, patient went into v fib at 00:02.  patient shocked at 150 joules in less than 10 second of rhythm change.  remained in v fib, 4 additional subsequent shocks given at 200 joules without conversion to perfusing rhythm.  cpr started and rosc achieved 00:04.  attending cath lab physician commented on concern with the defibrillator pads and the inability to convert the patient out of v fib. patient's electrolytes were within normal limits.When pads removed post procedure in icu, red skin/burn type marks noted on patient's right upper chest (where pad located) and left lower chest outlined marks.Per philips, need to determine if they need to open a new case number or if this can be added to previous complaints related to the pads.
Event or Problem Description
Cath lab nurse noted pads were in place and appeared adhered to skin during cath lab patient prep.During cath lab intervention, patient went into v fib at 00:02.Patient shocked at 150 joules in less than 10 second of rhythm change.Remained in v fib, 4 additional subsequent shocks given at 200 joules without conversion to perfusing rhythm.Cpr started and rosc achieved 00:04.Attending cath lab physician commented on concern with the defibrillator pads and the inability to convert the patient out of v fib.Patient's electrolytes were within normal limits.When pads removed post procedure in icu, red skin/burn type marks noted on patient's right upper chest (where pad located) and left lower chest outlined marks.Per philips, need to determine if they need to open a new case number or if this can be added to previous complaints related to the pads.

• Brand Name: PHILIPS HEARTSTART SMARTPADS 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: 16511999
• Report Number: 16511999
• Device Sequence Number: 12354093
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 02/28/2023