Model Number RT319 |
Device Problems
Misconnection (1399); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of 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 rt319 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system was incorrectly connected to the rt017 exhalation port.A ventilator leak alarm was triggered and the staff corrected the connection.There was no patient consequences.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt319 bi-level/cpap breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt319 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system was incorrectly connected to the rt017 exhalation port.A ventilator leak alarm was triggerred and the staff corrected the connection.Conclusion: based on the information provided, the reported incorrect connection of the rt319 bi-level/cpap breathing circuit to the rt017 exhalation port component was a result of user error.There was no reported damage or malfunction with the rt319 bi-level/cpap breathing circuit.The user instructions that accompany the rt319 bi-level/cpap breathing circuit include a pictorial showing the instructions to connect the circuit and exhalation port correctly.It also includes the following: - check all connections are tight before use.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- for use under the supervision of trained medical personnel.
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Event Description
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A healthcare facility in japan reported, via a fisher & paykel healthcare (f&p) field representative, that the rt319 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system was incorrectly connected to the rt017 exhalation port.A ventilator leak alarm was triggered and the staff corrected the connection.There was no patient consequence.
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Search Alerts/Recalls
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