Model Number MR850 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint mr850 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.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 audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.
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Manufacturer Narrative
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Ps384096 method: the complaint mr850 respiratory humidifier was returned to the fisher & paykel healthcare (f&p) service center in japan where it was inspected by a trained f&p personnel.The device was performance tested and the audible alarm was checked.Results: performance testing revealed that the audible alarm of the mr850 respiratory humidifier was not functioning.Conclusion: we are unable to determine what may have caused the reported failure.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 heater base.In addition the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 is equipped with visual alarm indicators in addition to the audible alarm.
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Event Description
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A distributor in japan reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.
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Search Alerts/Recalls
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