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Submission date: 11/06/2018.An investigation was performed for the reported customer complaint: ¿the customer states when commissioning the cadence electrodes, there was a contact problem with the connection to the cables.¿ a review of the device history record (dhr) for lot no.811330x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Quality assurance testing for this product also includes an array of electrical tests; dc offset voltage, ac small signal impedance, defibrillation recovery, noise, large signal impedance, simulated defib recovery, pacing impedance, pacing offset voltage, wave form duration and pacing energy loss.All were performed with passing results per manufacturing requirements.Dhr records were also reviewed for all defib gel body subassemblies utilized in the production of this product.All were within acceptance criteria, including visual inspections and electrical testing.No abnormal processing conditions or testing results were identified.Review of the wire/connector plugs incoming receipt inspection records identified no issues.Incoming inspection records included system <(>&<)> pin to pin dielectric testing and continuity testing.During production of the finished electrode there are two different steps whereby the connector is plugged into a receptacle (replicates plugging into therapy cord) that would cull out (reject the connector plug) any molding defects that would impair the connection.As part of the final assembly process of the defib electrode each defib electrode set is tested for continuity to ensure that the connector/gel body assembly is capable of conducting current, and that it demonstrates electrical continuity.Should this continuity test fail, the product would be discarded.Lastly, prior to packaging the final defib electrode assembly, the product is 100% visually inspected.During quality aql sample testing defib electrodes are subjected to full electrical testing which includes ecg <(>&<)> defibrillation shock <(>&<)> pacing requirements.All results were within the acceptance criteria for this production lot.The customer returned two (2) defib electrode sets for evaluation along with one pouch.The pouch indicated lot number 811330x.The defib electrode sets were visually inspected.All components were present and constructed per product specifications.The gel bodies were inspected for silver print, the printed silver pattern on the conductive gel bodies met the acceptance criteria.A therapy cable fit test was performed on the returned electrodes.The connectors plugged in with ease, no issues observed on the two defib electrode sets.The two electrode sets were subjected to a full array of tests in accordance with internal inspection protocol for defib properties (included shocking <(>&<)> pacing).Both of the electrode sets were recognized by the defibrillator unit.During the test the wires were manipulated throughout the process.The defib electrode set did not cut out.The test results were within the acceptance criteria to completely satisfy the manufacturing requirements per the product specification.The sets were also subjected to dielectric withstand testing to confirm the wires had not been comprised (damage to insulation).No issues were observed.Five (5) sets of production retained product from lot 817308x were also evaluated.The production retains were visually inspected for compromised wires and gel body assemblies that could contribute the reported event.No abnormalities were observed.All components were present and constructed per the product specifications.The gel bodies were inspected for silver print, the printed silver pattern on the conductive gel bodies met the acceptance criteria.A therapy cable fit test was performed on the five electrodes.The connectors plugged in with ease, with no issues observed.Each defib electrode set was then connected to a lifepak 20 defibrillator using a patient therapy plug.All five of the electrode sets were recognized by the defibrillator unit.The defibrillator recognized the electrodes immediately.While the electrodes were plugged into the defibrillator unit the wires were manipulated, defib electrodes did not cut out.From a potential root cause analysis perspective there are several important factors that can impact the adhesion of the product resulting in reading/tracing issues.Improper application of the electrode or applications without proper skin preparation can cause a failure to adhere properly resulting in reading/tracing issues.In order ecg signals to pass from the body to the electrode, an electrically conductive path between the skin and electrodes must be established to ensure adequate electrode impedance or contact impedance.Successful ecg and/or defibrillation requires electricity to flow from one electrode to the other through the chest.If the electrodes are not firmly adhered and there is sweat or another conductive material between the electrodes, the electricity will be more likely to flow across the chest rather than through it.Electrode pads must come in direct contact with the skin (no air pockets).If the chest hair is so excessive as to prevent good adhesion of the electrode pad, the hair should be removed.Another potential root cause is the patient therapy code used to connect the defibrillator.If the defib connector is not properly plugged into the patient therapy cord or if the therapy cord is damaged or the plug has a poor connection, the clinician could experience issues as described in the complaint.It is also important that the electrodes be connected to the patient (or test analyzer unit) before connection to the defibrillator.The defibrillator may produce a ¿check electrodes¿ warning if the electrodes are plugged in before they are connected to a patient- that does not mean there is a problem with the electrodes.The defibrillator sends a small amount of electrical current through the electrodes to determine if a patient is connected.This test requires a complete electrical circuit between the patient and the defibrillator.If the electrical circuit is not complete (¿open-circuit¿), the defibrillator may give a ¿check electrodes¿ warning.If the defibrillator gives a ¿check electrodes¿ warning after the electrodes are connected to the patient, the clinician should examine the connection between the electrodes and the patient to ensure adequate adhesion.There are several common sources of adhesion issues related to the usage practices.First, issues may arise when the patient¿s skin is not prepared properly prior to application.As previously stated, if the chest hair is so excessive as to prevent good adhesion of the electrode pad, the hair should be removed.The skin needs to be thoroughly dry before applying the electrodes.If the electrode adhesive is covered with dirt, oils, or dead skin cells, it will not adequately adhere to the patient¿s skin.Second, the electrodes cannot stretch and contract as much as human skin can.Movement of the patient after application of the electrodes should therefore be minimized.Electrodes should be placed on relaxed skin (not stretched or contracted) if possible.Third, electrodes placed on a patient¿s back can be peeled off when the patient is slid from bed to another.Electrodes should therefore be placed after the patient transfer if possible.Finally, the electrode can dry out as a result of the package being left open for an extended period of time.The following are instructions included in the product labeling note for the user relevant to ensuring proper adhesion and application of the electrode to the patient: -remove excess hair -clean and dry skin sites.Do not use alcohol or tincture of benzoin.-smooth the electrode from the center outward to the edges with fingertips to ensure that there are no air pockets between the gel and the patient¿s skin.-electrodes are not repositionable.Replace with new electrodes if repositioning is required.This will ensure optimal adhesion and minimize potential patient skin burns.-replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.As well as the following warnings to -do not use if electrode or pouch is damaged (if the pouch is damaged (compromised seal/hole in pouch) the hydrogel would be compromised potentially causing it to become dry which could impair electrode/contact impedance resulting in delayed ecg trace.) -do not open package until immediately prior to use.Important: replace the electrode pads after 24 hours on skin or 50 defibrillation shocks.-do not crush, fold, or store under heavy objects.Failure to comply with any of these instructions for use or warnings may result in the customer described incident.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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