Catalog Number 5347 |
Device Problems
Device Damaged Prior to Use (2284); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this report has been returned to the manufacturer and the investigation is in progress.
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Event Description
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Customer complaint alleges that upon "opening for using the respirator was already torn, so the physician could not use it." the alleged defect was reported as prior to use.There was no report of patient involvement.
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Manufacturer Narrative
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(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the respirator was torn along the neck of the bag.The products are 100% leak tested at the manufacturing facility prior to release and a defect of this type would be detected in the assembly line; therefore, the defect occurred after delivery.An attempt was made to duplicate the defect; however, the residual bags could not be torn.This defect was not caused by material aging.It was also observed that the name plate was damaged on the returned sample, indicating that the product was damaged during transportation.
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Event Description
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Customer complaint alleges that upon "opening for using the respirator was already torn, so the physician could not use it." the alleged defect was reported as prior to use.There was no report of patient involvement.
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Search Alerts/Recalls
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