MAUDE Adverse Event Report: CONMED CORPORATION R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR; R2 MFE / DEFIB PADS

Catalog Number 3200-1715

Device Problems Detachment Of Device Component (1104); Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 06/06/2014

Event Type  Death  

Manufacturer Narrative

As reported, the two (2) devices allegedly associated with this reported event were discarded by the end-user.Samples from the same lot were expected to be returned to conmed corporation for evaluation.However, despite multiple attempts, to date no lot samples were received for evaluation.In addition, no visual evidence (photographs) of the alleged "damaged pads" was provided by the end-user.Without the involved devices, an evaluation therefore could not be performed and the root cause of this reported "wire was hanging out of the pad" could not be determined.A review of the lot history record showed this lot was manufactured on (b)(6) 2013.Of the lot containing 500 units, there were no similar complaints received.A review of the dhr found there were no issues or abnormalities noted during the manufacturing process that could have caused or contributed to the reported problem.Additionally, a 2-year review of the complaint history for this device reveals the alleged problem of "damaged pads" as an isolated incident.During this same two year period there were over 28048 devices sold making the occurrence rate for this reported failure mode 0.003 percent.Per the end-user complaint report which indicated that the (b)(6), male patient was "too far gone".The reporter was sure the patient would not have made it, and they are not linking the alleged "damaged pad" directly to the reported patient death.This was further confirmed with the on-scene emergency medical personnel that the patient death was not directly related to the alleged device malfunction.The r2 mfe, multi-function electrode, is intended for use during defibrillation, cardioversion, pacing, and ecg monitoring applications.This product is a single use, disposable device.To ensure proper function of the r2 multi-function electrode and to reduce the risk of patient injury, the ifu (instructions for use) provides the following precautions and warnings: - misuse, 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.- avoid storage of electrodes where they may become subject to excessive heat or cold.Multi-function electrodes should be stored in unopened pouches at room temperature.- do not fold, trim, crush, or store electrodes under heavy objects.- do not use if packaging appears to be compromised.Damaged packaging may cause the conductive polymer gel to dry out.Lot samples never returned.

Event Description

It was reported, "we noticed this on a call last friday, went to defib a patient and it would not shock the pt.We did not notice the wire was hanging out of the pad.We opened another package and that had the same problem.I'm sure the patient would not have made it anyways, too far gone." this occurred in the field with the county ems personnel.The patient associated with this incident died.

Manufacturer Narrative

The devices associated with this reported incident have been discarded by the end-user facility; therefore, an evaluation on the suspect device will not be accomplished.Lot samples are expected to be returned to conmed corporation; however, these lot samples have not been received to date.Per the end-user complaint report, the patient was, "too far gone" the reporter was sure the patient would not have made it - thus they are not linking the device malfunction directly to the reported patient death.This was confirmed with the complaint reporter that the patient death was not directly related to the reported device malfunction.Upon completion of the quality engineering evaluation, a supplemental report will be filed.Device discarded by end-user.

• Brand Name: R2MULTIFUNCTION ELECTRODES, MFE, R2 CONNECTOR
• Type of Device: R2 MFE / DEFIB PADS
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 1 136; MX CP 1136
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3927163
• MDR Text Key: 12228760
• Report Number: 3007305485-2014-00075
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 3200-1715
• Device Lot Number: 1309064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2013
• 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: 94 YR
• Patient Weight: 130