SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Catalog Number C1120 |
Device Problems
Crack (1135); Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the unit's inspiratory filter connection was cracked, there was a hole in circuit, and there was leaking when water test was performed.No patient injury was reported.
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Manufacturer Narrative
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(udi) and g5 (510k) are unknown; no additional information was provided.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, a device history record (dhr) review could not be completed.The sample consisted of three (3) products from unknown lots, received in used conditions without their original packaging.Visual and functional testing were performed.Visual inspection: the samples were visually inspected at a distance of 12 inches under normal lighting to received unit, in order to detect any damage on the unit; two (2) samples have a tear.Functional test: one (1) sample was tested due to confirmation of leaking failure mode.Leak test was performed and the circuit did not pass the leak test.The root cause was deemed to be manufacturing-related.Actions (s) taken to mitigate the reported issue(s): a corrective and preventative action has been opened to address the reported issue.
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Search Alerts/Recalls
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