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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. EDGE SYSTEM AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand NameEDGE SYSTEM
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC.
11811 willows road ne
redmond WA 98052
MDR Report Key12597985
MDR Text Key275480280
Report Number12597985
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11996
Device Catalogue Number11996-000017
Device Lot Number115155
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2021
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer10/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
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