MAUDE Adverse Event Report: COVIDIEN KENDALL 1410Z MULTI- FUNCTION DEFIBRILLATION ELECTRODE; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 31469219

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

Patient scheduled for cardioversion due to a-fib.Once there, the physician checked the placement of the pads and proceeded to cardiovert the patient.Set at 150 joules, the device was discharged and at that point there was sparking from the pad area.A new pair of pads where then put in place removing the pair that sparked.Second attempt was successful.The patient was examined for burns post procedure and there were no signs of a burn.The nurse did a last check of his chest prior to discharge and no signs of a burn where noticed.

• Brand Name: KENDALL 1410Z MULTI- FUNCTION DEFIBRILLATION ELECTRODE
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 3763212
• MDR Text Key: 4464607
• Report Number: 3763212
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2014

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: Physician
• Device Model Number: 31469219
• Device Lot Number: 402708X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; ZOLL DEFIBRILLATOR
• Patient Age: 60 YR