MAUDE Adverse Event Report: CONMED CORPORATION UNKNOWN; MULTIFUNCTION ELECTRODES

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 05/02/2017

Event Type  Death  

Manufacturer Narrative

The reported device was discarded by the user; therefore, an evaluation was not performed and verification of the complaint is not possible.A catalog number and lot number were reported as unknown.A review of the manufacturing documents was not possible due to this information not being provided.A two-year review of historical complaint data revealed four similar complaints involving six devices have been reported.(b)(4).The application process is as follows.-tear open the pouch and remove the electrodes.-ensure the skin is clean and dry, clipping excess hair.-remove the release liner from the electrodes.-apply the electrodes to the patient by rolling the electrode from top to bottom.-ensure that the total surface area of the electrode is in contact with the skin.-connect the electrodes to the defibrillator cable.The directions for use caution the user: -misuse of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.-do not apply any substance to the skin surface that will leave a residue, i.E.Lotions, oils, etc.-if the electrodes do not adhere properly to the patient, apply new pair.-after application, keep the multifunction electrodes and surrounding area free from fluids.-do not re-apply if removed.An investigation has been initiated to determine if corrective/preventative actions are required.This reported issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

A medical service officer reported an incident with stryker involving their lifepak 15 machine.Stryker performed an evaluation and determined the event may be related to conmed electrodes that were used with this device.An emergency call was placed reporting a young male with an extensive medical history was in cardiac arrest.Upon arrival, paramedics noted the patient was lying on his back, unresponsive and had an asystole rhythm.Cpr was performed and intubation was attempted but excessive blood was encountered in the airway.The airway was suctioned and lungs revealed sounds of "crackles" bilaterally.The medic stated the device then dumped the defibrillator charge several times.A second set of defibrillation electrodes were placed on the patient and this did not resolve the issue.A backup defibrillator was then used and the issue was resolved.After twenty minutes with no change in patient, resuscitation efforts ceased.A review of the event record stored by the lifepak 15 indicated six occasions where the defibrillator charge was removed when the device operator pressed the speed dial selector knob on the lifepak 15 machine.This appeared to be intentional as the patient was not in a shockable rhythm.During another nine defibrillator charge attempts, the charge was removed due to an intermittent loss of connection to the patient through the defibrillation electrodes.This was indicated by very high patient impedance and erratic impedance trace.Despite multiple attempts, additional information about the patient/alleged device/event were not able to be obtained.The conmed electrodes were disposed of by the user.Same lot samples were not returned to stryker and will not be returned to conmed.

• Brand Name: UNKNOWN
• Type of Device: MULTIFUNCTION ELECTRODES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502-5994 ; 7273995209
• MDR Report Key: 6717227
• MDR Text Key: 80155970
• Report Number: 1320894-2017-00162
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Emergency Medical Technician
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 20 YR