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

Model Number 11996

Device Problems Device Emits Odor (1425); Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Erythema (1840); Unspecified Tissue Injury (4559)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

Out-patient received for tee (transesophageal echocardiogram) with cardioversion.Patient anesthetized.Tee performed without incident.Afib (atrial fibrillation) identified.Patient cardioverted with 200 joules.Remained in afib.Joules raised to 300 and during second attempt at cardioversion there was a spark from anterior pad.Staff noted electrical odor.Pads removed.Patient noted to have two purplish red areas under anterior pad, measuring approximately 3 inches at mid anterior chest and a quarter sized circular injury at the 4th intercostal space, left of sternum.Wounds dry, no blisters.Patient discharged to home after otherwise successful procedure.Manufacturer response for defibrillator, physio control (per site reporter): still in progress.

• Brand Name: EDGE SYSTEM
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 12597985
• MDR Text Key: 275480280
• Report Number: 12597985
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Model Number: 11996
• Device Catalogue Number: 11996-000017
• Device Lot Number: 115155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2021
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA