Model Number RT102 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
Event Type
malfunction
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Event Description
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A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher and paykel healthcare (f&p) field representative, that the connector of two rt102 adult inspiratory-heated breathing circuits disconnected during set-up.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The rt102 adult inspiratory-heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.We are currently in the process of completing 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 reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative, that the connector of two rt102 adult inspiratory-heated breathing circuits disconnected during set-up.There was no patient involvement.
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Manufacturer Narrative
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Ps384828, the rt102 adult inspiratory-heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.The complaint rt102 adult inspiratory-heated breathing circuits were not returned to f&p for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph showed the patient end connector not fully inserted into the inspiratory tube.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt102 adult inspiratory-heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt102 adult inspiratory-heated breathing 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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