MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. DEFIBRILLATOR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	11996-000090
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon completing a cardiac cardioversion staff noted sparks coming from defibrillator pad on patient's chest.After cardioversion completed upon removing pad, patient was left with reddened burned area near pad placement.Fda safety report id# (b)(4).

• Brand Name: DEFIBRILLATOR PADS
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; redmond WA 98052
• MDR Report Key: 14547605
• Report Number: MW5109980
• Device Sequence Number: 6113254
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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 Expiration Date: 07/10/2024
• Device Model Number: 11996-000090
• Device Catalogue Number: 11996-000090
• Device Lot Number: 204527
• 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: 05/27/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male