Expiration date: 08/2019.Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: a total of (b)(4) cases are associated with this complaint.A separate fda form 3500a has been completed for that case.
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A preliminary evaluation of the reported cases were reviewed collectively due to similar failure modes reported for tubing disconnecting from mask.These complaints included a review of complaints reported between october 27, 2014 to october 27, 2016 (2 year period) for this failure.Additionally, the last product monitoring reviews (pmrs) were also reviewed and no trends were identified.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on december 27, 2016.
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