The last three (3) product monitoring reviews (pmrs) were reviewed and none of the affected product codes have illustrated any trends for product category or any malfunction or any harm.More specifically, there were no trends observed for oxygen masks.Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of nozzle issues.A total of three (3) complaints were reported from a single complaint.No trends were observed and no harms reported.In all cases, the product was discontinued and replaced.Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of blocked oxygen tubing.A total of one (1) complaint was reported.No trends were observed and no harms reported.In all cases, the product was discontinued and replaced.These issues 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 january 13, 2017.
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