Model Number RT109 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This product is not sold in the usa however it is similar to a product which is sold in the usa.The 510(k) for the similar product is k983112.Device 1: lot# 2101123411, dom (b)(6) 2020.Device 2: lot# 2101127912, dom (b)(6) 2020.The two complaint rt109 adult anaesthesia circuits were received at fisher & paykel healthcare (f&p) in (b)(6).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A distributor in (b)(4) reported that the connection between the y-piece and two rt109 adult anaesthesia circuits disconnected after 1 day of use.There was no reported patient consequence.
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Event Description
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A distributor in japan reported that the connection between the y-piece and two rt109 adult anaesthesia circuits disconnected after 1 day of use.There was no reported patient consequence.
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Manufacturer Narrative
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(b)(4).Section g4: this product is not sold in the usa however it is similar to a product which is sold in the usa.The 510(k) for the similar product is k983112.Section h4: device 1: lot# 2101123411, dom 05/23/2020.Device 2: lot# 2101127912, dom 05/20/2020.Method: the two complaint rt109 adult anaesthesia circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation where they were visually inspected.Results: visual inspection of both circuits revealed no damage to the y-piece or the tube cuffs.For both circuits, a tight connection between the tube and the y-piece connector was found.Conclusion: we were unable to determine what may have caused the reported event.All rt109 adult anaesthesia circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt109 adult anaesthesia circuits state the following: "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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Search Alerts/Recalls
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