Model Number RT105 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/07/2021 |
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 distributor reported on behalf of a healthcare facility in (b)(6), via a fisher and paykel healthcare (f&p) field representative, that four rt105 adult breathing circuits did not pass the ventilator leak test during set-up and were found leaking from the water trap.There was no patient involvement.
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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 four rt105 adult breathing circuits did not pass the ventilator leak test during set-up and were found leaking from the water trap.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the three of the four complaint (b)(4) adult breathing circuits were returned to fisher & paykel healthcare in (b)(6) where they were visually inspected and pressure tested.Results: pressure testing revealed that one of the three complaint circuits was out of specification.The water bath test revealed that the leak was through the connection between the lid and bowl of the water trap.Visual inspection revealed that the sealing edge of the bowl was found deformed.Conclusion: we are unable to determine what caused the damage to the water trap of the breathing circuit.However based on the information provided, it is possible that the damage was caused when the caregiver opened the watertrap before use.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt105 adult breathing circuit 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 connecting to a patient.Set appropriate ventilator alarms.
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Search Alerts/Recalls
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