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

Model Number 11150-000019

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Patient underwent scheduled cardioversion at bedside.Cardinalhealth medi-trace cadence adult multi-function defibrillator pads were placed on the patient's chest and back for procedure.Cardioverted x2 @ 200 joules each time.After procedure, pads were removed and the pad on the back left a red burn mark on the patient's skin.

• Brand Name: LIFEPACK 20E PHYSIO-CONTROL DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER/PHYSIO-CONTROL, INC.; redmond WA 98052
• MDR Report Key: 18518327
• MDR Text Key: 333047643
• Report Number: MW5150225
• 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: 01/12/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White