|
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.
|
|
Submitted date: 12/04/2018.An investigation was performed for the reported customer complaint: the customer states after external pacing at 200ma, the lifepak unit didn't recognize the electrodes anymore and displayed "electrode not recognized".Unplugging and re-plugging the electrodes solved the issue for 15 mins, but the same error showed up again.¿ a review of the device history records (dhr) for reported lot number 734238x indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.All defib electrode and subassembly components met the required quality assurance tests and acceptance criteria to completely satisfy the manufacturing requirements per the product specification.Quality assurance testing included 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 were performed.In addition, the dhr for the defib gel body subassembly used in defib product 22550pc, lot 734238x was reviewed.The dhr for product sr00020 (defib gel body subassembly), lot 733513, passed all acceptance criteria, including visuals and electricals.No abnormal processing conditions or testing results were identified.During production of the finished electrode there are two different steps whereby the connector is plug 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.Production retains from production lot 734238x (3 sets) were evaluated.The production retains were visually inspected for compromised wires and gel body assemblies that could contribute the event as described in the complaint, no abnormalities were observed.All components were present and were 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.The production retains were subjected to an ecg testing in accordance with internal inspection protocol for electrical properties.All results were within the acceptance criteria to completely satisfy the manufacturing requirements per the product specification.Each defib electrode set was then connected to a lifepak 20 defibrillator using a patient therapy plug.The defibrillator recognized the electrodes immediately.The production retains were then subjected to a defib shocking and pacing tests in accordance with internal inspection protocols.All results were within the acceptance criteria to completely satisfy the manufacturing requirements per the product specification.All results were within the acceptance criteria.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.To follow are the 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.There are also 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 the electrode set hair on the foam adhesive and gel body (remnants of shaved hair).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.Another potential root cause is the patient therapy cord 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, the clinician could experience issues as described in the complaint.Given the information provided in the complaint and investigation, no root cause or probable root cause could be identified related to manufacturing or deviations from specifications.The complaint report indicated the product was not available for return because the customer discarded.Therefore, a comprehensive investigation could not be performed.However, production retains passed all testing.The reported customer complaint could not be 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.
|
