MAUDE Adverse Event Report: CONMED CORPORATION PADPRO® DEFIBRILLATION/PACE/CARDIOVERSION/MONITORING PADS; PADPRO MFES

Catalog Number	2516M
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) sets of 2516m padpro defibrillation/pace/cardioversion/monitoring pads have been returned to the conmed quality assurance laboratory for evaluation regarding a complaint of "pads failed to defibrillate." the devices were examined and functionally tested in the laboratory; a visual inspection noted the electrodes were received with the gel layer of the pad pairs stuck together.The electrode pairs were slowly and carefully peeled apart to expose the gel layers without disturbing gel and gel foil adhesion.When separated, a continuity test was performed and confirmed the circuit from pad foil to terminal was complete.The devices were subsequently functionally tested using a fluke impulse 7000dp defibrillator analyzer for producing ecg wave and energy output measurement and a lifepak20e for waveform monitoring and defibrillator, as well as a lifepak15 with pacing to create pacing waveform.The two returned padpro devices, reported to not defibrillate, showed no failures for defibrillation, waveform monitoring or pacing.The devices were also tested for specification compliance using cmet testing (conmed electrode testing).This is a custom device that tests the defibrillator pads to the iec 60601-2-4, 2010 standards (dco, aczs 10hz, aczs 30khz, dor, and aczl).All iec 60601-2-4 specific electrical specifications were found in compliance.Both devices performed to specifications with all electrical testing and with simulated use functional testing.Conmed was unable to replicate the reported event.(b)(4).To date, there have been no patient long term effects reported regarding this isolated incident.The padpro defibrillation/pace/cardioversion/monitoring pads are intended for use during defibrillation, cardioversion, pacing, and ecg monitoring applications.This product is a single-use, disposable device.To reduce the risk of patient injury, the ifu, instructions for use, provides the following warnings and precautions: do not fold, trim, crush, or store under heavy objects.Make sure the skin is dry, i.E.Free of water, sweat , alcohol, etc.Do not apply any substance to the skin surface that will leave a residue, i.E.Lotions, oils, etc.Do not apply the electrodes over broken skin.If the electrodes do not adhere properly to the patient, apply a new pair.Do not reapply if removed.Avoid storage of electrodes where they may be subject to excessive heat or cold.Electrodes should be stored in unopened pouches at room temperature.Misuse of multi-function 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.
Event or Problem Description
On (b)(6) 2015 patient went into cardiac arrest at the end-user facility.Two (2) unsuccessful attempts to defibrillate the patient were done with a lifepak-20 defibrillator and a two (2) separate sets of padpro mfes, multi-function electrodes, catalog number 2516m, lot y03171509.Both of these set-ups failed to defibrillate.A third set of pad pro mfes was attached to the patient, different lot number, and the patient was successfully defibrillated.There was a two minute delay due to the need to change the mfes on the patient.The patient was transported to critical care unit in stable condition.Current status of patient is reported by end-user facility as "fine".

• Brand Name: PADPRO® DEFIBRILLATION/PACE/CARDIOVERSION/MONITORING PADS
• Common Device Name: PADPRO MFES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5392686
• Report Number: 1320894-2016-00001
• Device Sequence Number: 844067
• Product Code: MKJ
• UDI-Device Identifier: 10653405042624
• UDI-Public: (01)10653405042624(17)180320(30)1(10)Y03171509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K020203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Report Date (Section B): 01/04/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2018
• Device Catalogue Number: 2516M
• Device Lot Number: Y03171509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 79