Investigation conclusion: the reported complaint stated a therapist was using an electrical stimulation modality on a patient.The therapist noticed a spark and some smoke at the location of the wire and pad attachment.We believe the pad/wire may be faulty.Additional information provided regarding the event impact to patient: there was no harm to the patient.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product and failure mode trending was reviewed, and no related adverse trends were identified.The process failure modes and effects analysis (pfmea) was reviewed to ensure all risks associated with the product have been identified.A total of ten (10) products were returned for evaluation six (6) pouches were received unopened and four (4) pouches were received opened with unused electrodes.One (1) electrode, included within the four (4) open and unused pouches, contained black spots and was stuck to paper, thus, making it difficult to analyze its electrical properties.Functional evaluation of the returned product was not performed as the product was deemed compromised.The construction of the electrode was examined and met quality specifications.In summary, a review of the equipment, material, manufacturing process and probable root cause of the reported product failure was performed, and the reported product failure was not confirmed.A root cause was unable to be determined, however, it should be noted that the reported product is not intended to be used with a power source.Corrective actions taken were limited to manufacturer awareness.This complaint will be recorded and used for monitoring and trending purposes.
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