MAUDE Adverse Event Report: CONMED CORPORATION R2 PAD:PCQC DC;ADULT NON-RTL; R2 DEFIB PADS:MEDTRONIC

Catalog Number 3112-1731

Device Problems Loose or Intermittent Connection (1371); Intermittent Shock/Stimulation (2287)

Patient Problem Sudden Cardiac Death (2510)

Event Date 05/12/2017

Event Type  Death  

Manufacturer Narrative

The actual complaint device was discarded by the customer.A root cause could not be determined for the alleged "intermittent loss of connection to the patient through the defibrillation electrodes" without examination of the actual device.One customer stock sample was sent to conmed by (b)(6) fire and ems for evaluation.The chief of the fire department stated this stock sample was stored just as they store all electrodes which is in a folded position inserted on a shelf in the ambulance.The device was received in its original unopened package.Visual inspection identified wrinkles on the edge of the pads.A lot sample was taken to inspect for a potential lot defect of wrinkling and the sample met specification.Functional testing of the returned product was performed using a lifepak 12 machine.The lifepak 12 was tested on three different energy outputs, 200j/280j/380j, and delivered the energy to the device.The device was also tested with a reduced contact surface and the charge was delivered successfully.The cable was intentionally forced to work intermittently by not fully connecting it to the lifepak 12, however, this would be obvious to the user and prompt the user to stabilize the connection before proceeding.A two-year review of complaint history shows no previous complaints reported for this device.(b)(4).The lot number of the actual device was not provided; therefore, a review of the manufacturing documents was not possible.The instructions for use caution the user and advise the user of the following.-do not fold, trim, crush, or store under heavy objects.-avoid storage of electrodes where they may be subject to excessive heat or cold.Electrodes should be stored in unopened pouches at room temperature.-temperature, humidity and transportation environmental limitations -application: ensure skin is clean and dry and apply the electrodes to the patient by rolling the electrode from top to bottom.Ensure the total surface area of the electrode is in contact with the skin.Connect the electrodes to the defibrillator cable.-if the electrodes do not adhere properly to the patient, apply a new pair.This incident will be investigated further through the capa system and will continue to be monitored by the complaint system to assure product safety.

Event Description

The stryker representative was notified of a patient death involving the use of their life pak 12 and therapy cable as well as conmed electrodes.As reported, an attempt was made to use a life pak 12 defibrillator/monitor to administer shocks to a patient diagnosed in cardiac arrest.Conmed defibrillation electrodes were connected to the patient.The defibrillator charge was reportedly disarmed.Additional patient information and event details were obtained through communication with the chief of the fire department.On (b)(6) 2017, emergency medical services were called and notified of an obese patient in cardiac arrest.The patient had a reported history of iv drug and pharmaceutical abuse with no previous cardiac history.The patient was unresponsive and had no pulse when paramedics arrived on scene.Chest compressions were initiated, the patient was successfully intubated and medications were administered by way of intraosseous infusion (io).Defibrillation was attempted multiple times, however, only the first charge was delivered to the patient successfully.The charge was continually dumped by the life pak 12 due to loose connections.Patient was moved to the ambulance and transported to the hospital.Upon arrival at the hospital, the patients' cardiac rhythm showed asystole.The patient was not resuscitated.

• Brand Name: R2 PAD:PCQC DC;ADULT NON-RTL
• Type of Device: R2 DEFIB PADS:MEDTRONIC
• 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: 6710403
• MDR Text Key: 79927274
• Report Number: 3007305485-2017-00157
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Catalogue Number: 3112-1731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 34 YR