Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the device history paperwork was reviewed for all lots, specifically reviewing the foam and snap lots to determine what lots were used and when.There were multiple lots of both the snaps and foam used during production.There were samples returned from lot 314665.Visual inspection reveals some of the snaps were broken.The wire connector was mated with the returned samples.The connector/snap mating found that some of the snaps were difficult to press into the connector.However, no electrodes disconnected from the device.Also, peel testing could not be performed on the foam of the returned samples as the strip label was impacting the adhesion results, skewing them to a much higher result.Therefore, the reported failure could not be duplicated/reproduced, and the root cause could not be determined.Though, the broken snap may contribute to the connector and electrode mating issue.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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