Model Number RT210 |
Device Problems
Disconnection (1171); Leak/Splash (1354); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
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Event Description
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A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).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 healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
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Manufacturer Narrative
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(b)(4), method: the complaint rt210 adult dual-heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the expiratory heater wire moulded plug of rt210 circuit was loose.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The subject breathing circuits would have met the required specifications at time of production.The user instructions that accompany the rt210 adult dual-heated breathing circuitt state the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Visually inspect breathing sets for damage before use and replace if damaged.
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Search Alerts/Recalls
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