This is filed to report the potential serious injuries related to the 20/30 priority pack / indeflator.It was reported through the post-market clinical follow-up evaluation (pmcf) report, that the 20/30 priority pack / indeflator may be related to the adverse patient effects of air embolism, arrhythmia and dissection and the device malfunctions of leak, loose connection and break.Details are listed in the attached pmcf, titled post-market clinical follow-up evaluation report accessories and indeflators.Please see pmcf for specific information.
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Date of event ¿ estimated.The devices were not returned for analysis.Review of the lot history records and similar incident review could not be conducted because the part and lot numbers were not provided.Due to the limited information available, the investigation determined a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other reportable events referenced in the pmcf are filed under separate medwatch report numbers.Attachment: post-market clinical follow-up evaluation report accessories and indeflators.
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