MAUDE Adverse Event Report: STRYKER / PHYSIO-CONTROL, INC. LIFEPAK 20E PHYSICO-CONTROL DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 11150-000019

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/29/2023

Event Type  Injury  

Event Description

Patient undergoing bedside tee(transesophageal echocardiography)/cardioversion.Cardinalhealth medi-trace cadence adult multi-function defibrillation pads were placed on patient's chest and back.Burning smell noted after cardioversion.When defibrillation pads were removed from the patient chest wall, outline with burn appearance on patient's chest wall was noted.300j and 360j utilized.

• Brand Name: LIFEPAK 20E PHYSICO-CONTROL DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER / PHYSIO-CONTROL, INC.; redmond WA 98052
• MDR Report Key: 18526965
• MDR Text Key: 333104637
• Report Number: MW5150408
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 11150-000019
• Device Catalogue Number: 3314164-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 169 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White